# K133175: Draeger Jaundice Meter JM-105

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Nov 13, 2014 after 392 days
- Product code: MQM (Bilirubin (Total And Unbound) In The Neonate Test System)
- Device class: 1
- Regulation: 21 CFR 862.1113
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P810007 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042522: Jaundice Meter, Model JM 103, Draeger Medical Infant Care, Inc. (2005) Summary page 4.

## Recalls of this device
- May 15, 2018 · Class I · Z-2047-2018: Users have misinterpreted the display for out of range measurement indicated by the blinking "-0-" to mean a zero measurement

## Indications for use
The Jaundice Meter (JM-105) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals, clinics or doctor’s offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose JM-105 Jaundice Meter test results are indicative of hyperbilirubinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. The JM 105 is a prescription medical device The JM 105 is not intended for home use. The JM 105 may only be used at the sternum measurement site for Physician’s office applications.

Source page: https://510kreport.com/device/K133175
Methodology: https://510kreport.com/methodology