510(k) · Cleared
ClearedBilichek Non-Invasive Bilirubin Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on Mar 4, 1999 after a 183-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 4, 1999
- Review
- 183 days
- Class
- Class I
- Product code
- MQM
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983071 Bilichek Non-Invasive Bilirubin AnalyzerRespironics, Inc. · 1999
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K983071 | Bilichek Non-Invasive Bilirubin Analyzer | Respironics, Inc. | 1999 | — |
| +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 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994438 | Bilichek Non-Invasive Bilirubin Analyzer | 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?
- Of its descendants, K994438 (Spectrx, Inc., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQM devicesMQM 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
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 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 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983071: Bilichek Non-Invasive Bilirubin Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983071
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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