510(k) · Cleared
ClearedAvl Opti 1 PH/Blood Gas 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 Apr 26, 1996 as substantially equivalent to K895317 (Avl Scientific Corp., 1990) and 1 other predicate after a 35-day review. Its family tree reaches back 1 generation to 1990. 6 later devices descend from it.
- Decided
- Apr 26, 1996
- Review
- 35 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895317 (1990). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK895317 Avl Model 995HB PH/Blood Gas AnalyzerAvl Scientific Corp. · 1990
- This deviceK961161 Avl Opti 1 PH/Blood Gas AnalyzerAvl Scientific Corp. · 1996
- Descendant · cites it directly · 5 of its ownK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- Descendant · cites it directly · 4 of its ownK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- 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 · 3 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K974784Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly5descendants
- K984299Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998 · cites it directly4descendants
- K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
- K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 2 generations on1descendant
- 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 | K895317 | Avl Model 995HB PH/Blood Gas Analyzer | Avl Scientific Corp. | 1990 | — |
| 0 (this device) | K961161 | Avl Opti 1 PH/Blood Gas Analyzer | Avl Scientific Corp. | 1996 | — |
| +1 | K974784 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +1 | K984299 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| +1 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| +2 | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +3 | K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K895317 | Avl Model 995HB PH/Blood Gas AnalyzerSummary page 1…OPTI 1 pH/Blood Gas Analyzer. Additionally, as in the former 510(k) submission, the AVL OPTI 1 is substantially equivalent to the AVL Model 995 pH / Blood Gas Analyzer [K895317] and AVL COMPACT 2 pH / Blood Gas Analyzer [K942616]. Description of the new device The AVL OPTI 1 is a microprocessor-based in… | 1990 |
| * | K942616 | Avl Compact 2 PH/Blood Gas AnalyzerSummary page 1…he former 510(k) submission, the AVL OPTI 1 is substantially equivalent to the AVL Model 995 pH / Blood Gas Analyzer [K895317] and AVL COMPACT 2 pH / Blood Gas Analyzer [K942616]. Description of the new device The AVL OPTI 1 is a microprocessor-based instrument using optical fluorescence for the measurem… | 1994 |
What descends from it? (6)
3 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)
No FDA recall names this device.
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 OPTI 1 pH/ Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood in either a traditional blood gas or clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
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/K961161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961161: Avl Opti 1 PH/Blood Gas Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961161
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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