Draeger Jaundice Meter JM-105

A skin meter that gives a digital reading of yellowness in a newborn, to help clinicians monitor jaundice. In the United States it is cleared as a prescription device for hospitals, clinics and doctors' offices, not for home use; in a physician's office it may only be used at the sternum site. Its readings should be confirmed by a blood test before treatment decisions.

Also called JM-105 · Jaundice Meter JM-105

Product
In this atlas

Overview

Technical summary

FDA 510(k) K133175, decision 13 November 2014, product code MQM, regulation 21 CFR 862.1113 (bilirubin in the neonate test system), regulatory class I, reserved (clearance letter). Applicant: Draeger Medical Systems, Inc. The Indications for Use call it a non-invasive transcutaneous bilirubinometer that is not a standalone for diagnosing hyperbilirubinemia. The openFDA record lists device class 1 and decision code SESE (substantially equivalent).

Product details

Type: Device
Model or formulation: Jaundice Meter JM-105, a non-invasive transcutaneous bilirubinometer
Version: As cleared under 510(k) K133175 on 2014-11-13 (Draeger Medical Systems, Inc.). Later versions are not covered.

Intended-use sources

Background FDA 510(k) premarket notification K133175: Draeger Jaundice Meter JM-105 (openFDA record and the FDA clearance letter with indications for use)

Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record (dataset last updated 2026-10-05) and the FDA 510(k) clearance letter and Indications for Use form, a PDF dated November 13, 2014, fetched from accessdata.fda.gov (mh-fda-510k-summary-k133175.pdf). · 510(k): K133175

Locator
Whole source

How it applies
Source of the stated intended use

Retrieved
2026-10-14T18:25:57Z

Source effective date
2014-11-13

Source state
Current

Snapshot hash
bc9d9c593a56d9b0f41f4843c8fd78ff82a09b2b92ebd8f30079d4d0c3a98745

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/mh-openfda-510k-k133175.json. The PDF is an FDA document whose reuse terms were not read, so its bytes are not committed and quotations from it stay short.

Claims and evidence

Context Newborn infants measured with the Jaundice Meter JM-105 in US hospitals, clinics and doctors' offices

Recipient: Newborn
Population: Newborn infants. The meter is a prescription device used under a physician's supervision; it is not intended for home use.
Care setting: Hospitals, clinics or doctors' offices, under physician supervision or direction.
Geography: United States (FDA clearance)
Life stage: Newborn infants
Gestational age: Not reported
Postnatal age: Not reported
Follow-up: Not applicable: a device clearance, not a study.

Eligibility: 1 inclusion criterion; 1 exclusion criterion

Included: Newborn infants monitored by clinicians in hospitals, clinics or doctors' offices
Excluded: Home use

Regulatory Evidence stage not applicable Certainty not assessed

FDA cleared the Draeger Jaundice Meter JM-105 under 510(k) K133175 on 13 November 2014 as a non-invasive transcutaneous bilirubinometer. It measures yellowness of the tissue under the skin in newborn infants and gives a digital reading that has been shown to correlate with serum bilirubin. It is meant to help clinicians monitor newborn infants in hospitals, clinics or doctors' offices, under a physician's supervision. It is not intended as a standalone for diagnosing high bilirubin: it is used with other clinical signs and laboratory measurements, and bilirubin levels should be confirmed by other methods, such as serum bilirubin, before treatment decisions. It is a prescription device and is not intended for home use. In a physician's office it may only be used at the sternum measurement site.
Applies to Newborn
- Newborn infants. The meter is a prescription device used under a physician's supervision; it is not intended for home use.
- Hospitals, clinics or doctors' offices, under physician supervision or direction.
- United States (FDA clearance)
- Newborn infants
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Not applicable: a device clearance, not a study.
Certainty method
Not assessed

Limitations
The statement rests on the FDA clearance letter and Indications for Use form. A 510(k) clearance means FDA found the device substantially equivalent to a predicate device; it is not a finding of clinical benefit. The clearance is for the United States, and the regulatory class on the letter is I, reserved.

Last checked
Not recorded

Next evidence check due
Not scheduled
Sources and citations (3)
1. Supports FDA 510(k) premarket notification K133175: Draeger Jaundice Meter JM-105 (openFDA record and the FDA clearance letter with indications for use)
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record (dataset last updated 2026-10-05) and the FDA 510(k) clearance letter and Indications for Use form, a PDF dated November 13, 2014, fetched from accessdata.fda.gov (mh-fda-510k-summary-k133175.pdf). · 510(k): K133175
  
  Locator
  Indications for Use
  
  How it applies
  The cleared indications.
  
  Retrieved
  2026-10-14T18:25:57Z
  
  Source effective date
  2014-11-13
  
  Source state
  Current
  
  Snapshot hash
  bc9d9c593a56d9b0f41f4843c8fd78ff82a09b2b92ebd8f30079d4d0c3a98745
  
  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/mh-openfda-510k-k133175.json. The PDF is an FDA document whose reuse terms were not read, so its bytes are not committed and quotations from it stay short.
2. Supports FDA 510(k) premarket notification K133175: Draeger Jaundice Meter JM-105 (openFDA record and the FDA clearance letter with indications for use)
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record (dataset last updated 2026-10-05) and the FDA 510(k) clearance letter and Indications for Use form, a PDF dated November 13, 2014, fetched from accessdata.fda.gov (mh-fda-510k-summary-k133175.pdf). · 510(k): K133175
  
  Locator
  openFDA 510(k) record
  
  How it applies
  Number, decision and date.
  
  Retrieved
  2026-10-14T18:23:58Z
  
  Source effective date
  2026-10-05
  
  Source state
  Current
  
  Snapshot hash
  01d72a20ab61c0293c215e62fcb976e0d874522ba4c037d0806e60a7cf61f085
  
  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/mh-openfda-510k-k133175.json. The PDF is an FDA document whose reuse terms were not read, so its bytes are not committed and quotations from it stay short.
3. Background FDA 510(k) premarket notification K133175: Draeger Jaundice Meter JM-105 (openFDA record and the FDA clearance letter with indications for use)
  
  Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA 510(k) endpoint record (dataset last updated 2026-10-05) and the FDA 510(k) clearance letter and Indications for Use form, a PDF dated November 13, 2014, fetched from accessdata.fda.gov (mh-fda-510k-summary-k133175.pdf). · 510(k): K133175
  
  Locator
  Clearance letter, Regulatory Class
  
  How it applies
  Regulatory class as printed on the letter.
  
  Retrieved
  2026-10-14T18:25:57Z
  
  Source effective date
  2014-11-13
  
  Source state
  Current
  
  Snapshot hash
  bc9d9c593a56d9b0f41f4843c8fd78ff82a09b2b92ebd8f30079d4d0c3a98745
  
  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/mh-openfda-510k-k133175.json. The PDF is an FDA document whose reuse terms were not read, so its bytes are not committed and quotations from it stay short.

Authorization

Regulatory decision: Draeger Jaundice Meter JM-105

Applies to Newborn

Newborn infants. The meter is a prescription device used under a physician's supervision; it is not intended for home use.
Hospitals, clinics or doctors' offices, under physician supervision or direction.
United States (FDA clearance)
Newborn infants
Gestational age Not reported
Postnatal age Not reported

Follow-up Not applicable: a device clearance, not a study.

Authority: U.S. Food and Drug Administration
Decision: Clearance, 2014-11-13
Pathway: 510(k)
Submission: K133175
Product code: MQM
Device class: Class I
Jurisdictions: United States; note: United States
Product version: Jaundice Meter JM-105 as cleared under K133175 (Draeger Medical Systems, Inc.)
Indication: A non-invasive transcutaneous bilirubinometer that measures yellowness of subcutaneous tissue in newborn infants, to assist clinicians in monitoring newborn infants in hospitals, clinics or doctors' offices under physician supervision. It is not a standalone for diagnosis of hyperbilirubinemia, bilirubin levels should be confirmed by other methods such as serum bilirubin before treatment decisions, it is a prescription device, it is not for home use and in a physician's office it may only be used at the sternum measurement site.

Basis: FDA cleared the Draeger Jaundice Meter JM-105 under 510(k) K133175 on 13 November 2014 as a non-invasive transcutaneous bilirubinometer. It measures yellowness of the tissue under the skin in newborn infants and gives a digital reading that has been shown to correlate with serum bilirubin. It is meant to help clinicians monitor newborn infants in hospitals, clinics or doctors' offices, under a physician's supervision. It is not intended as a standalone for diagnosing high bilirubin: it is used with other clinical signs and laboratory measurements, and bilirubin levels should be confirmed by other methods, such as serum bilirubin, before treatment decisions. It is a prescription device and is not intended for home use. In a physician's office it may only be used at the sternum measurement site.
Limitations. The statement rests on the FDA clearance letter and Indications for Use form. A 510(k) clearance means FDA found the device substantially equivalent to a predicate device; it is not a finding of clinical benefit. The clearance is for the United States, and the regulatory class on the letter is I, reserved.

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

Record details

Record id: maternal:draeger-jm-105
Content hash: 3053cf78b9f337d144363ce19241939f9924ddb85c96d99606fee04db85f9a56