510(k) Report

510(k) · Cleared

Cleared

Bilichek Non-Invasive Bilirubin Analyzer

K994438510(k) TraditionalCleared Feb 4, 200036-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

Spectrx, Inc. · MQM Bilirubin (Total And Unbound) In The Neonate Test System

Cleared on Feb 4, 2000 as substantially equivalent to K983071 (Respironics, Inc., 1999) and 2 other predicates after a 36-day review. Its family tree reaches back 2 generations to 1992.

Decided
Feb 4, 2000
Review
36 days
Class
Class I
Product code
MQM
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K922770 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK922770 · Unistat Bilirubinometer Models 10310 and 10311 · Leica, Inc. · 1992K964590 · Colormate Iii · Chromatics Color Sciences Intl., Inc. · 19971990199219941996199820002002
Other ancestors, by generation 1 generation back: 1 other ancestor K964590 · Colormate Iii · Chromatics Color Sciences Intl., Inc. · 1997K922770 · Unistat Bilirubinometer Models 10310 and 10311 · Leica, Inc. · 19920
  1. Root · 2 generations backK922770 Unistat Bilirubinometer Models 10310 and 10311Leica, Inc. · 1992
  2. 1 generation backK964590 Colormate IiiChromatics Color Sciences Intl., Inc. · 1997
  3. This deviceK994438 Bilichek Non-Invasive Bilirubin AnalyzerSpectrx, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K922770Unistat Bilirubinometer Models 10310 and 10311Leica, Inc.1992—
−1K964590Colormate IiiChromatics Color Sciences Intl., Inc.1997—
0 (this device)K994438Bilichek Non-Invasive Bilirubin AnalyzerSpectrx, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K994438, 1992–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K983071Bilichek Non-Invasive Bilirubin Analyzer
Summary page 1
…analyzer Classification Name: Bilirubin (total and unbound) in the neonate tes (21 CFR 862.1113) PREDICATE DEVICES Respironics BiliChek Non-invasive Bilirubin Analyzer (K983071) Chromatics III (K964590) Leica Unistat Bilirubinometer (K922770). DEVICE DESCRIPTION t system The Bilichek consists of the Bi…
Respironics, Inc.1999—
*K964590Colormate Iii
Summary page 1
…ame: Bilirubin (total and unbound) in the neonate tes (21 CFR 862.1113) PREDICATE DEVICES Respironics BiliChek Non-invasive Bilirubin Analyzer (K983071) Chromatics III (K964590) Leica Unistat Bilirubinometer (K922770). DEVICE DESCRIPTION t system The Bilichek consists of the BiliChek hand-held unit, th…
Chromatics Color Sciences Intl., Inc.1997—
*K922770Unistat Bilirubinometer Models 10310 and 10311
Summary page 1
…e neonate tes (21 CFR 862.1113) PREDICATE DEVICES Respironics BiliChek Non-invasive Bilirubin Analyzer (K983071) Chromatics III (K964590) Leica Unistat Bilirubinometer (K922770). DEVICE DESCRIPTION t system The Bilichek consists of the BiliChek hand-held unit, the BiliCal Individual calibration tips, a…
Leica, Inc.1992—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • None of the 3 ancestors has a recall.

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

2008: 12011: 12014: 22017: 1
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

2007: 52008: 32010: 42011: 32012: 42014: 12015: 12016: 12017: 12018: 52019: 62020: 12021: 12023: 142024: 172025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—05
20081—03
20090—00
20100—04
20111—03
20120—04
20130—00
20142—01
20150—01
20160—01
20171—01
20180—05
20190—06
20200—01
20210—01
20220—00
20230—014
20240—017
20250—02
20260—0—

What is it indicated for?

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…

Read the full statement (114 words)

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 Chromatography (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.

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

More from Spectrx, Inc.

2 FDA decisions under this applicant name. See the company

  • K051045Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30Spectrx, Inc. · 2005

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The MQM category page

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https://510kreport.com/device/K994438 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994438: Bilichek Non-Invasive Bilirubin Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994438

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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