# K972309: JM-102 Jaundice Meter

- Pathway: 510(k) (Traditional)
- Applicant: Air-Shields, Inc.
- Decided: Sep 22, 1998 after 459 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: 1 generation back to P810007 (1981). 1 ancestor in all.
3 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)
- P810007: Jaundice Meter 101, Narco Scientific (1981) Summary page 1.

## Most influential descendants
- K021622: Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103 (2003), 2 descendants of its own
- 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 JM-102 Jaundice Meter provides an objective index of icterus in infants and when used in conjunction with other clinical signs and/or laboratory measurements, can assist the physician in making clinical decisions regarding the need for serum bilirubin measurements.

Source page: https://510kreport.com/device/K972309
Methodology: https://510kreport.com/methodology