510(k) · Cleared
ClearedOPTI® B-Lac Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Opti Medical Systems, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Aug 2, 2021 as substantially equivalent to K092686 (Radiometer Medical Aps, 2010) and 1 other predicate after a 474-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Aug 2, 2021
- Review
- 474 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K861087 (1986). 38 ancestors in all, the oldest K823480 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 6 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 5 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 4 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 3 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 2 generations backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- 1 generation backK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- This deviceK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −6 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −5 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −4 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −2 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| −1 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| 0 (this device) | K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2013 | 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 14.2 · 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 |
|---|---|---|---|
| * | K092686 | ABL90 Flex SeriesSummary page 7…ted in Table 1Table 1, the OPTI® B-Lac Cassette is substantially equivalent to significant characteristics of the identified predicate device, the Radiometer ABL90 Flex (K092686) and the OPTI CCA TS2 E-Series Cassettes (K131126). 510(k) Premarket Notification CONFIDENTIAL AND PROPRIETARY… | 2010 |
| * | K131126 | Opti Cca-TS2Summary page 5…the pH or PO2 sensors or the measurement of tHb or SO2 (Saturated Oxygen). In addition, changes to the software that were made to the OPTI CCA-TS (K984299) and CCA-TS2 (K131126), referred to as OPTI CCA-TS/TS2, to implement the algorithms for the PCO2, sensors are documented. 2. DEVICE DESCRIPTION… | 2013 |
| * | — | Instrumentation Laboratory GEM Premier 4000 Named without a submission number |
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 35 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 16 of the 38 ancestors have a recall of any class.
- 5 other devices also cite its predicate K092686.
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. 2021, this device’s year, is highlighted.
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 OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, PCO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
» Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
» Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
* Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.
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/K200986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200986: OPTI® B-Lac Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200986
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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