{ "release_id": "fc5a600ec7387e71", "id": "maternal:snoo-smart-sleeper", "owner": "maternal", "kind": "product", "slug": "snoo-smart-sleeper", "name": "SNOO Smart Sleeper (infant bassinet with supine-position system)", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-14", "last_evidence_check": "2026-10-14", "next_review_due": null, "identifiers": [ { "scheme": "fda-product-code", "value": "QTG", "normalized_value": "QTG", "match": "broad", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "infant-follow-up" ], "care-area": [ "infant-health" ] } }, "payload": { "subtype": "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_snapshots": [ "maternal:fda-denovo-summary-den210039-2026-10-14" ] }, "content_digest": "999ebe150c473dcb7f19d8981217ef35eefdf4e2789a1b98d3b9bb1b3e535212", "review": { "content_digest": "999ebe150c473dcb7f19d8981217ef35eefdf4e2789a1b98d3b9bb1b3e535212", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "fc5a600ec7387e71", "id": "maternal:claim-fda-den210039-granted", "owner": "maternal", "subject_entity_id": "maternal:snoo-smart-sleeper", "category": "regulatory", "statement": "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.", "context": { "id": "maternal:ctx-fda-den210039-infants-birth-to-6-months-not-rolling", "label": "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_note": "Newborn and young infant, birth to 6 months of age", "life_stage_terms": { "maternal": [ "newborn", "infant-follow-up" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (regulatory context)", "eligibility": { "inclusion": [ "Infants from birth to 6 months of age who are not yet able to roll over consistently" ], "exclusion": [ "Infants who can push up on hands and knees, can roll over consistently, or have reached 6 months of age, whichever comes first" ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "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. 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