510(k) · Cleared
Recalled · 2003Avl Omni Modular Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avl Scientific Corp. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jan 29, 1999 as substantially equivalent to K960120 (Nova Biomedical Corp., 1996) and 2 other predicates after an 18-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 29, 1999
- Review
- 18 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 1 generation to K940918 (1994). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK940918 I-Stat 200 Portable Clinical AnalyzerI-Stat Corp. · 1994 · Recalled
- This deviceK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999
- Descendant · cites it directly · 2 of its ownK013373 Omni C AnalyzerRoche Diagnostics Corp. · 2001 · Recalled
- Descendant · cites it directly · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK032311 Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003 · Recalled
- Descendant · 3 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K013373Omni C AnalyzerRoche Diagnostics Corp. · 2001 · cites it directly2descendants
- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
- K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 2 generations on1descendant
- K032311Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003 · cites it directly1descendant
- K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940918 | I-Stat 200 Portable Clinical Analyzer | I-Stat Corp. | 1994 | 19 |
| 0 (this device) | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | — |
| +1 | K013373 | Omni C Analyzer | Roche Diagnostics Corp. | 2001 | 1 |
| +1 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| +2 | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +1 | K032311 | Roche Diagnostics Omni S Analyzer | Roche Diagnostics Corp. | 2003 | 9 |
| +3 | K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021 | — |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 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 CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K960120 | Stat Profile Ultra F,G,H,I,J, and K AnalyzersSummary page 1…o a number of currently marketed devices known as 'Combi Analyzers.' The Urea Nitrogen method is specifically equivalent to that employed in the NOVA Biomedical ULTRA H [K960120] and the i-STAT 200 Portable Clinical Analyzer (K940918). As demonstrated by the clinical tests included with the attached, the u… | 1996 |
| * | K940918 | I-Stat 200 Portable Clinical AnalyzerSummary page 1…Analyzers.' The Urea Nitrogen method is specifically equivalent to that employed in the NOVA Biomedical ULTRA H [K960120] and the i-STAT 200 Portable Clinical Analyzer (K940918). As demonstrated by the clinical tests included with the attached, the urea nitrogen value reported by the OMNI™ is equivalent t… | 1994 |
| * | K953239 | Boehringer Mannheim/Hitachi 917 AnalyzerSummary page 1…ogen value reported by the OMNI™ is equivalent to that obtained from analysis of the same sample by a photometric method on the Boehringer Mannheim/Hitachi 917 Analyzer (K953239). - 510(k) Summary AVL OMNI Combi Analyzer ) *) (6) Description of the new device The AVL OMNI™ Analyzer is… | 1995 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2003 | Not classified | Z-0336-04 | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. |
| Dec 29, 2003 | Not classified | Z-0335-04 | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. |
| Dec 29, 2003 | Not classified | Z-0337-04 | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. |
| 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?
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO,, PO,, ctHb, HHb, O,Hb, COHb, MetHb, SulfHb, Na’, K’, CI', ionized Ca"’, Hematocrit, glucose, lactate and urea nitrogen in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.
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/K990092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990092: Avl Omni Modular Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990092
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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