# K961161: Avl Opti 1 PH/Blood Gas Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Apr 26, 1996 after 35 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895317 (1990). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895317: Avl Model 995HB PH/Blood Gas Analyzer, Avl Scientific Corp. (1990) Summary page 1.
- K942616: Avl Compact 2 PH/Blood Gas Analyzer, Avl Scientific Corp. (1994) Summary page 1.

## Most influential descendants
- K974784: Avl Opti Critical Care Analyzer (1998), 5 descendants of its own
- K984299: Avl Opti Critical Care Analyzer (1998), 4 descendants of its own
- K993837: Avl Opti Critical Care Analyzer (1999), 2 descendants of its own
- K131126: Opti Cca-TS2 (2013), 1 descendant of its own
- K200986: OPTI® B-Lac Cassette (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K961161
Methodology: https://510kreport.com/methodology