SNOO Smart Sleeper (infant bassinet with supine-position system)

A bassinet with a swaddle-style Sleep Sack that clips to the bassinet to keep a baby on the back during sleep, with sound and motion. In 2023 FDA authorised it for babies from birth to 6 months who cannot yet roll over, for use at home. FDA says it has not been shown directly to reduce SIDS or sudden unexpected infant death.

Product
In this atlas

Overview

Technical summary

FDA De Novo DEN210039 granted 2023-03-30 (openFDA), applicant Happiest Baby, Inc., product code QTG, Class II. It created the device type infant supine sleep system (21 CFR 880.5690) with special controls. The summary describes a bassinet and Sleep Sack jointly intended to facilitate a supine position during sleep for infants from birth to 6 months who cannot yet roll over consistently, and lists limits: not for infants who can push up on hands and knees or roll over consistently, not a substitute for adult supervision. The company reported supine position in about 98.7% of 1012 users and, among 106,723 users, no increase in reported SIDS or SUID against historical data; FDA found the data not good enough for a precise rate and required a postmarket surveillance study. The authorisation covers supine positioning, not prevention of SIDS or SUID. The recipient is the infant.

Product details

Type: Device
Model or formulation: SNOO bassinet with SNOO Sleep Sack (swaddle with fixed wings that clip to the bassinet), with sound and motion and a companion app, as described in the FDA decision summary
Version: As authorised under De Novo DEN210039 (decision date 2023-03-30). Later changes to the device were not read.

Intended-use sources

Background De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary

Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.

Locator
Whole source

How it applies
Source of the stated intended use

Retrieved
2026-10-14T18:24:12Z

Source effective date
Not reported

Source state
Current

Snapshot hash
f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6

Reuse basis
FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.

Claims and evidence

Context Infants from birth to 6 months who cannot yet roll over consistently, home use (SNOO Smart Sleeper, United States)

Recipient: Child
Population: Infants from birth to 6 months of age who are not yet able to roll over consistently, cared for at home by caregivers.
Care setting: Home use by caregivers.
Geography: United States (FDA)
Life stage: Newborn and young infant, birth to 6 months of age
Gestational age: Not reported
Postnatal age: Not reported
Follow-up: Not applicable (regulatory context)

Eligibility: 1 inclusion criterion; 1 exclusion criterion

Included: Infants from birth to 6 months of age who are not yet able to roll over consistently
Excluded: Infants who can push up on hands and knees, can roll over consistently, or have reached 6 months of age, whichever comes first

Regulatory Evidence stage not applicable Certainty not assessed

FDA granted De Novo request DEN210039 for the SNOO Smart Sleeper on 30 March 2023 (openFDA decision date) and classified the new device type, the infant supine sleep system (21 CFR 880.5690), as Class II. FDA's summary says the bassinet and its Sleep Sack are jointly intended to help an infant stay on the back during sleep, for home use by caregivers of infants from birth to 6 months of age who cannot yet roll over consistently. FDA's summary also says the device has not directly demonstrated a reduction in the incidence of SIDS or SUID, so the labeling must carry a warning that the device has not been demonstrated to reduce that risk.
Applies to Child
- Infants from birth to 6 months of age who are not yet able to roll over consistently, cared for at home by caregivers.
- Home use by caregivers.
- United States (FDA)
- Newborn and young infant, birth to 6 months of age
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Certainty method
Not assessed

Limitations
The authorisation covers helping an infant stay in a supine sleep position within the stated age and ability limits. It does not cover prevention of SIDS or SUID, and FDA says so. The company's real-world data reported a supine position in about 98.7% of 1012 users and, in 106,723 users, no increase in reported SIDS or SUID against historical national data; FDA said the data were not good enough to give a precise SIDS or SUID rate, and required a postmarket surveillance study in higher-risk US subpopulations. A De Novo grant is not a recommendation to use the device, and safe sleep advice from public health sources is recorded separately on the safe infant sleep page. The text layer of the FDA PDF prints the device name inconsistently, with a zero in some places, and quotations repeat it as extracted.

Last checked
2026-10-14

Next evidence check due
Not scheduled
Sources and citations (12)
1. Supports FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record)
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · De Novo: DEN210039
  
  Locator
  results[0].decision_date
  
  How it applies
  Decision date in openFDA.
  
  Retrieved
  2026-10-14T18:18:26Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  ecac6edf131ec217a5b7b09aeff9c71ffb94bff13b4e43a2436a02cb2a98151e
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The raw record is committed. It includes a contact name and an address that FDA publishes; records here do not repeat them. The raw file is committed at research/snapshots/mj-openfda-510k-den210039.json.
2. Supports FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record)
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · De Novo: DEN210039
  
  Locator
  results[0].k_number
  
  How it applies
  De Novo number in openFDA.
  
  Retrieved
  2026-10-14T18:18:26Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  ecac6edf131ec217a5b7b09aeff9c71ffb94bff13b4e43a2436a02cb2a98151e
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The raw record is committed. It includes a contact name and an address that FDA publishes; records here do not repeat them. The raw file is committed at research/snapshots/mj-openfda-510k-den210039.json.
3. Supports FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record)
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record, from a dataset last updated 2026-10-05. · De Novo: DEN210039
  
  Locator
  results[0].product_code
  
  How it applies
  Product code in openFDA.
  
  Retrieved
  2026-10-14T18:18:26Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  ecac6edf131ec217a5b7b09aeff9c71ffb94bff13b4e43a2436a02cb2a98151e
  
  Reuse basis
  openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication unless noted (https://open.fda.gov/terms/, https://open.fda.gov/license/). The raw record is committed. It includes a contact name and an address that FDA publishes; records here do not repeat them. The raw file is committed at research/snapshots/mj-openfda-510k-den210039.json.
4. Supports De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Regulatory information, generic type
  
  How it applies
  FDA description of the device type.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
5. Supports De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Regulatory information, classification
  
  How it applies
  Classification in the decision summary.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
6. Supports De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Indications for use, paragraph 1
  
  How it applies
  Intended population and setting, part 1.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
7. Supports De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Limitations, paragraph 2
  
  How it applies
  Use limited to infants who cannot consistently roll over.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
8. Supports De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Limitations, paragraph 1
  
  How it applies
  FDA statement that SIDS/SUID reduction was not directly shown.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
9. Supports De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Labeling, item a
  
  How it applies
  Labeling must carry a warning that a reduction in SIDS or SUID risk has not been shown.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
10. Background De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Summary of clinical information, paragraph 1
  
  How it applies
  Company real-world evidence on supine position.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
11. Background De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary
  
  Regulator · U.S. Food and Drug Administration (CDRH) · Edition The decision summary PDF, 8 pages, fetched on 2026-10-14. Its text layer prints the device name inconsistently (SNOO in some places and SNO0, with a zero, in others); quotations repeat the text exactly as extracted. The accessdata denovo.cfm page was fetched too (mj-fda-denovo-page-DEN210039.html) and was not used.
  
  Locator
  Postmarket surveillance
  
  How it applies
  Postmarket surveillance requirement.
  
  Retrieved
  2026-10-14T18:24:12Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  f1f923890f7894cba63b75965ba5f303404ed1c74db0afa51d93c799aa182af6
  
  Reuse basis
  FDA website policies page (fetched as mj-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The PDF bytes are not committed. Short quotations with attribution.
12. Background 21 CFR 880.5690 Infant supine sleep system
  
  Regulator · Office of the Federal Register and U.S. Government Publishing Office (eCFR) · Edition eCFR versioner API text for the version dated 2026-10-01, fetched on 2026-10-14. The first two requests (mj-ecfr-880-5690.xml and mj-ecfr-880-5690-b.xml) returned HTTP 406 because they did not accept compression.
  
  Locator
  (a) Identification, sentence 1
  
  How it applies
  The regulation text for the new device type.
  
  Retrieved
  2026-10-14T18:24:28Z
  
  Source effective date
  Not reported
  
  Source state
  Current
  
  Snapshot hash
  fd6c5ae46a48c946118abae23b2f4dea2992cb7e75e3959055dedb4a53361cd1
  
  Reuse basis
  Text of a US federal regulation, committed at research/snapshots/mj-ecfr-880-5690-c.xml. The GovInfo Public Domain and Copyright Notice (fetched as mj-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government.

Authorization

Regulatory decision: SNOO Smart Sleeper (infant bassinet with supine-position system)

Applies to Child

Infants from birth to 6 months of age who are not yet able to roll over consistently, cared for at home by caregivers.
Home use by caregivers.
United States (FDA)
Newborn and young infant, birth to 6 months of age
Gestational age Not reported
Postnatal age Not reported

Follow-up Not applicable (regulatory context)

Authority: U.S. Food and Drug Administration
Decision: Granted, 2023-03-30
Pathway: De Novo
Submission: DEN210039
Product code: QTG
Device class: Class II
Jurisdictions: United States; note: United States
Product version: SNOO Smart Sleeper (bassinet with Sleep Sack), De Novo DEN210039
Indication: A bassinet and Sleep Sack jointly intended to facilitate a supine position during sleep, for home use by caregivers of infants from birth to 6 months of age who are not yet able to roll over consistently. FDA states the device has not directly demonstrated a reduction in the incidence of SIDS or SUID.

Basis: FDA granted De Novo request DEN210039 for the SNOO Smart Sleeper on 30 March 2023 (openFDA decision date) and classified the new device type, the infant supine sleep system (21 CFR 880.5690), as Class II. FDA's summary says the bassinet and its Sleep Sack are jointly intended to help an infant stay on the back during sleep, for home use by caregivers of infants from birth to 6 months of age who cannot yet roll over consistently. FDA's summary also says the device has not directly demonstrated a reduction in the incidence of SIDS or SUID, so the labeling must carry a warning that the device has not been demonstrated to reduce that risk.
Limitations. The authorisation covers helping an infant stay in a supine sleep position within the stated age and ability limits. It does not cover prevention of SIDS or SUID, and FDA says so. The company's real-world data reported a supine position in about 98.7% of 1012 users and, in 106,723 users, no increase in reported SIDS or SUID against historical national data; FDA said the data were not good enough to give a precise SIDS or SUID rate, and required a postmarket surveillance study in higher-risk US subpopulations. A De Novo grant is not a recommendation to use the device, and safe sleep advice from public health sources is recorded separately on the safe infant sleep page. The text layer of the FDA PDF prints the device name inconsistently, with a zero in some places, and quotations repeat it as extracted.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id: maternal:snoo-smart-sleeper
Content hash: 999ebe150c473dcb7f19d8981217ef35eefdf4e2789a1b98d3b9bb1b3e535212