510(k) · Cleared
ClearedBilirubin Assay on the Omni S Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · MQM Bilirubin (Total And Unbound) In The Neonate Test System
Cleared on May 14, 2004 as substantially equivalent to K981632 (Roche Diagnostics/Boehringer Mannheim GmbH, 1998) and 3 other predicates after a 109-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- May 14, 2004
- Review
- 109 days
- Class
- Class I
- Product code
- MQM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K952621 (1995). 12 ancestors in all, the oldest K781921 (1979). No later device cites it as a predicate yet.
- Root · 4 generations backK952621 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1995
- 3 generations backK962334 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1996 · Recalled
- 2 generations backK980130 ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998 · Recalled
- 1 generation backK991417 Abl 735 AnalyzerRadiometer America, Inc. · 1999 · Recalled
- This deviceK040174 Bilirubin Assay on the Omni S AnalyzerRoche Diagnostics Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952621 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1995 | — |
| −3 | K962334 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1996 | 1 |
| −2 | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | Radiometer America, Inc. | 1998 | 5 |
| −1 | K991417 | Abl 735 Analyzer | Radiometer America, Inc. | 1999 | 2 |
| 0 (this device) | K040174 | Bilirubin Assay on the Omni S Analyzer | Roche Diagnostics Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1984 | 1 | 0 |
| 1992 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentSummary page 1…er for use on the OMNI S Analyzer is substantially device equivalent to the legally marketed bilirubin assay on the Roche Hitachi Analyzers (K981632), the Radiometer ABL735 (K991417), the Beckman LX®20 System (KO I1213) and the Kodak Vitros System (K840880).… | 1998 |
| * | K991417 | Abl 735 AnalyzerSummary page 1…is substantially device equivalent to the legally marketed bilirubin assay on the Roche Hitachi Analyzers (K981632), the Radiometer ABL735 (K991417), the Beckman LX®20 System (KO I1213) and the Kodak Vitros System (K840880). 4) Device The Roche Diag… | 1999 |
| * | K011213 | Modification to Synchron LX 20 Clinical Chemistry System | 2001 |
| * | K840880 | Ektachem Clinical Chem. SlidesSummary page 1…Roche Hitachi Analyzers (K981632), the Radiometer ABL735 (K991417), the Beckman LX®20 System (KO I1213) and the Kodak Vitros System (K840880). 4) Device The Roche Diagnostics OMNI S Analyzer is a fully automated critical care Description analyzer intende… | 1984 |
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 9 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K981632.
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 Roche Diagnostics OMNI S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, P02, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040174: Bilirubin Assay on the Omni S Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040174
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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