510(k) · Cleared
ClearedOpti Cca-TS2
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 22, 2013 as substantially equivalent to K993837 (Avl Scientific Corp., 1999) after a 122-day review. Its family tree reaches back 6 generations to 1986. 1 later device descends from it.
- Decided
- Aug 22, 2013
- Review
- 122 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K861087 (1986). 23 ancestors in all, the oldest K823480 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 5 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 4 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 3 generations backK974784 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- 2 generations backK984299 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1998
- 1 generation backK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
- This deviceK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −5 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −4 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −3 | K974784 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| −2 | K984299 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1998 | — |
| −1 | K993837 | Avl Opti Critical Care Analyzer | Avl Scientific Corp. | 1999 | — |
| 0 (this device) | K131126 | Opti Cca-TS2 | Opti Medical Systems, Inc. | 2013 | — |
| +1 | 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 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K993837 | Avl Opti Critical Care AnalyzerSummary page 1…e of Submission OPTI Medical has designed and tested a new model (OPTI® CCA-TS2) of the OPTI® Critical Care Analyzer (OPTI® CCA-TS) previously cleared.for use with k993837 for the IVD measurement of pH, PCO2, P02, Nat , Kt , Catt , Cl, Glucose, BUN (urea), tHb and SO, and cleared for use with k093… | 1999 |
| † | K093280 | Opti Cca-TS, B-Lac Cassette Model BP7561 | 2011 |
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 |
|---|---|---|---|
| K200986 | OPTI® B-Lac Cassette | 2021 | 0 |
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 27 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K200986 (Opti Medical Systems, Inc., 2021) has gone furthest, with 0 descendants of its own.
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. 2013, 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 CCA-TS2 system when used with disposable cassettes containing parameter specific sensors isintended to be used for the measurement of pH, PCO 2, p02, Na, K*, Ca", C-, Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na+, r%Ca't Ci; Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations. * Measurements of blood gases KPC2, P02) and blood pH are used in the diagnosis and…
Read the full statement (323 words)
The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors isintended to be used for the measurement of pH, PCO 2, p02, Na, K*, Ca", C-, Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na+, r%Ca't Ci; Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations.
* Measurements of blood gases KPC2, P02) and blood pH are used in the diagnosis and treatment of life-threatening adid-base disturbances.
* Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
* Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
* Oxygen saturation (S02) measurement is used to determine the oxygen capacity of the hemoglobin.
* Potassium (K*) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
* Calcium (Ca') measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
* Sodium (Nat) measurements are used in the diagnosis and treatment of aldlosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst),adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
* Chloride (C1') measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
* Urea nitrogen (an end-product of nitrogen metabolism) measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
* Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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/K131126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131126: Opti Cca-TS2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131126
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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