# Draeger Jaundice Meter JM-105 Product · id `maternal:draeger-jm-105` · Maternal & Newborn Atlas · release `fc5a600ec7387e71` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: JM-105; Jaundice Meter JM-105 Browse, life stage: Newborn Browse, care area: Newborn care ## In plain language 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. ## 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). ## Claims, with the population each applies to ## 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. ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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. - 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 - Sources: 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, 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).) Locator: Indications for Use. Retrieved 2026-10-14T18:25:57Z. Source state: Current. Snapshot hash: bc9d9c593a56d9b0f41f4843c8fd78ff82a09b2b92ebd8f30079d4d0c3a98745. How it applies: The cleared indications. 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, 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).) Locator: openFDA 510(k) record. Retrieved 2026-10-14T18:23:58Z. Source state: Current. Snapshot hash: 01d72a20ab61c0293c215e62fcb976e0d874522ba4c037d0806e60a7cf61f085. How it applies: Number, decision and date. 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, 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).) Locator: Clearance letter, Regulatory Class. Retrieved 2026-10-14T18:25:57Z. Source state: Current. Snapshot hash: bc9d9c593a56d9b0f41f4843c8fd78ff82a09b2b92ebd8f30079d4d0c3a98745. How it applies: Regulatory class as printed on the letter. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k133175` - Product: Draeger Jaundice Meter JM-105 (`maternal:draeger-jm-105`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2014-11-13 - Product version: Jaundice Meter JM-105 as cleared under K133175 (Draeger Medical Systems, Inc.) - Pathway: 510(k) - Submission: K133175 - Product code: MQM - Device class: I - 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. - Jurisdictions: United States; note: United States - Applies to: 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. - Basis: claim `maternal:claim-fda-k133175-indication` ## Connected pages - Skin (transcutaneous) reading of yellowness: Bilirubin level in a newborn (skin or blood) (`maternal:bilirubin-newborn`) - Filed under this front: Screening and tests (`maternal:front-screening-and-tests`) ## Provenance Content hash: 6135c4afe76dd2f6ba3f0efe7a5f4c2e9f71f39e87776a49afefab7d312306d9 Last substantive edit: 2026-10-14 Evidence last checked: Not recorded