# K964590: Colormate Iii

- Pathway: 510(k) (Traditional)
- Applicant: Chromatics Color Sciences Intl., Inc.
- Decided: Jul 24, 1997 after 251 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 K922770 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922770: Unistat Bilirubinometer Models 10310 and 10311, Leica, Inc. (1992) Summary page 4.
- (no number) Ingram Icterometer: named in the summary without a submission number

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

## Indications for use
The Colormate III™ is to be used as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia. Following the physician’s examination within the first hours of birth, newborn babies are initially measured and periodically monitored by the Colormate III™ for incremental changes in the yellow content of the skin color as compared to the baseline Colormate III™ measurements. Babies with Colormate III™ test results indicative of hyperbilirubinemia are to be re-evaluated by the attending physician for appropriate patient management.

Source page: https://510kreport.com/device/K964590
Methodology: https://510kreport.com/methodology