510(k) · Cleared

Cleared

Colormate Iii

K964590510(k) TraditionalCleared Jul 24, 1997251-day reviewClass I21 CFR 862.1113

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Chromatics Color Sciences Intl., Inc. · MQM Bilirubin (Total And Unbound) In The Neonate Test System

Cleared on Jul 24, 1997 as substantially equivalent to K922770 (Leica, Inc., 1992) after a 251-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.

Decided: Jul 24, 1997
Review: 251 days
Class: Class I
Product code: MQM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K922770 (1992). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK922770 Unistat Bilirubinometer Models 10310 and 10311Leica, Inc. · 1992
This deviceK964590 Colormate IiiChromatics Color Sciences Intl., Inc. · 1997
Descendant · cites it directly · 0 of its ownK994438 Bilichek Non-Invasive Bilirubin AnalyzerSpectrx, Inc. · 2000

Most influential descendants

Showing 1 of 1 · See all

K994438Bilichek Non-Invasive Bilirubin AnalyzerSpectrx, Inc. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922770	Unistat Bilirubinometer Models 10310 and 10311	Leica, Inc.	1992	—
0 (this device)	K964590	Colormate Iii	Chromatics Color Sciences Intl., Inc.	1997	—
+1	K994438	Bilichek Non-Invasive Bilirubin Analyzer	Spectrx, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K964590, 1992–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MQM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K922770	Unistat Bilirubinometer Models 10310 and 10311 Summary page 4 …e, and safety and effectiveness to at 1least two legally marketed predicate devices. The first predicate device, the Unistat Bilirubinometer manufactured by Leica, Inc. (K922770), is a bilirubinometer which operates by measuring the absorption of visible 1light through a sample of unreacted serum. The abso…	Leica, Inc.	1992	—
*	—	Ingram Icterometer Named without a submission number			—

Also cleared against K922770: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K994438	Bilichek Non-Invasive Bilirubin Analyzer	Spectrx, Inc.	2000	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K994438 (Spectrx, Inc., 2000) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K922770.

How does its category compare?

All MQM devices

MQM Bilirubin (Total And Unbound) In The Neonate Test System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQM

1in 2017

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQM

Too few MQM 510(k)s in any year since 2007 to give a median.

Recalls per year · MQM

No recall names MQM since 2007.

Adverse event reports per year · MQM

2in 2025

2007high 17 (2024) · low 0 (2009)2025

MAUDE reports naming product code MQM, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	5
2008	1	—	3
2009	0	—	0
2010	0	—	4
2011	1	—	3
2012	0	—	4
2013	0	—	0
2014	2	—	1
2015	0	—	1
2016	0	—	1
2017	1	—	1
2018	0	—	5
2019	0	—	6
2020	0	—	1
2021	0	—	1
2022	0	—	0
2023	0	—	14
2024	0	—	17
2025	0	—	2
2026	0	—	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964590 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964590: Colormate Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964590

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026