# K983071: Bilichek Non-Invasive Bilirubin Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Mar 4, 1999 after 183 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K994438: Bilichek Non-Invasive Bilirubin Analyzer (2000), 0 descendants of its own

## Indications for use
The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The Bilichek™ provides a numerical measurement of predicted bilirubin count in mg/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromotography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose Bilichek™ test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

Source page: https://510kreport.com/device/K983071
Methodology: https://510kreport.com/methodology