510(k) · Cleared
Recalled · Class II · 2018Roche Diagnostics Omni S 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 Oct 17, 2003 as substantially equivalent to K990092 (Avl Scientific Corp., 1999) and 1 other predicate after an 81-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Oct 17, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940918 (1994). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK940918 I-Stat 200 Portable Clinical AnalyzerI-Stat Corp. · 1994 · Recalled
- 2 generations backK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · Recalled
- 1 generation backK013373 Omni C AnalyzerRoche Diagnostics Corp. · 2001 · Recalled
- This deviceK032311 Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003
- Descendant · cites it directly · 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 1 of 1 · See all- K111188Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack…Roche Diagnostics · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940918 | I-Stat 200 Portable Clinical Analyzer | I-Stat Corp. | 1994 | 19 |
| −2 | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | 4 |
| −1 | K013373 | Omni C Analyzer | Roche Diagnostics Corp. | 2001 | 1 |
| 0 (this device) | K032311 | Roche Diagnostics Omni S Analyzer | Roche Diagnostics Corp. | 2003 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K990092 | Avl Omni Modular AnalyzerSummary page 1…lobin, carboxyhemoglobin and methemoglobin. 3) Predicate We claim substantial equivalence to the current legally marketed Omni device Modular Analyzer (K990092) and the Omni C Analyzer (K013373). 4) Device The Omni S analyzer represents a combined pH, blood gas, electrolyte, Des… | 1999 |
| * | K013373 | Omni C AnalyzerSummary page 1…moglobin. 3) Predicate We claim substantial equivalence to the current legally marketed Omni device Modular Analyzer (K990092) and the Omni C Analyzer (K013373). 4) Device The Omni S analyzer represents a combined pH, blood gas, electrolyte, Description glucose, lactate, u… | 2001 |
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 |
|---|---|---|---|
| K111188 | Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack… | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2018 | Class II | Z-1611-2018 | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. |
| Feb 22, 2018 | Class II | Z-1613-2018 | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. |
| Feb 22, 2018 | Class II | Z-1610-2018 | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. |
| Feb 22, 2018 | Class II | Z-1612-2018 | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. |
| Oct 31, 2016 | Class II | Z-0673-2017 | Software design | Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second… |
| Jun 24, 2015 | Class II | Z-2330-2015 | Process control | The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until… |
| Dec 18, 2014 | Class II | Z-1041-2015 | Material/Component Contamination | Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected. |
| Sep 12, 2014 | Class III | Z-0064-2015 | Labeling Change Control | The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for… |
| Feb 28, 2014 | Class II | Z-1315-2014 | Device Design | Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K111188 (Roche Diagnostics, 2012) has gone furthest, with 0 descendants 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 S Analyzer is a fully automated critical care analyzer intended to
be used for the measurement of pH, P02, PC02, sodium, potassium, ionized calcium, chloride,
hematocrit, glucose, lactate, urea/BUN, 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/K032311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032311: Roche Diagnostics Omni S Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032311
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