# K021622: Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom Air-Shields
- Decided: Apr 1, 2003 after 320 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P810007 (1981). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972309: JM-102 Jaundice Meter, Air-Shields, Inc. (1998) Summary page 1.

## Most influential descendants
- K042522: Jaundice Meter, Model JM 103 (2005), 1 descendant of its own
- K133175: Draeger Jaundice Meter JM-105 (2014), 0 descendants of its own

## Indications for use
The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. 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 Jaundice Meter (JM 103) test results are indicative of hyperbilirubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. This device is not intended for home use.

Source page: https://510kreport.com/device/K021622
Methodology: https://510kreport.com/methodology