510(k) · Cleared
Recalled · 2002Omni C Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · CEM Electrode, Ion Specific, Potassium
Cleared on Nov 2, 2001 as substantially equivalent to K990092 (Avl Scientific Corp., 1999) after a 22-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940918 (1994). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK940918 I-Stat 200 Portable Clinical AnalyzerI-Stat Corp. · 1994 · Recalled
- 1 generation backK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · Recalled
- This deviceK013373 Omni C AnalyzerRoche Diagnostics Corp. · 2001
- Descendant · cites it directly · 1 of its ownK032311 Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003 · Recalled
- Descendant · 2 generations on · 0 of its ownK111188 Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B…Roche Diagnostics · 2012 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940918 | I-Stat 200 Portable Clinical Analyzer | I-Stat Corp. | 1994 | 19 |
| −1 | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | 4 |
| 0 (this device) | K013373 | Omni C Analyzer | Roche Diagnostics Corp. | 2001 | — |
| +1 | K032311 | Roche Diagnostics Omni S Analyzer | Roche Diagnostics Corp. | 2003 | 9 |
| +2 | K111188 | Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc… | Roche Diagnostics | 2012 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 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 CEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K990092 | Avl Omni Modular AnalyzerSummary page 2…pH, Blood Gas, Electrolyte, Hematocrit, Hemoglobin and Oxygen Saturation System We claim substantial equivalence to the current legally marketed Omni Modular Analyzer (K990092). The Omni C analyzer represents a combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test syst… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032311 | Roche Diagnostics Omni S Analyzer | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2002 | Not classified | Z-0438-03 | Other | Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K032311 (Roche Diagnostics Corp., 2003) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K990092.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, 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 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, P02, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate.
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/K013373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013373: Omni C Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013373
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026