# K993837: Avl Opti Critical Care Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Dec 16, 1999 after 34 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861087 (1986). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981426: Stat Profile Ultra F,G,H,I,J,K, and L Analyzers, Nova Biomedical Corp. (1998) Summary page 1.
- K946206: Ciba Corning 8-- Series CO-Oximeter, Ciba Corning Diagnostics Corp. (1995) Summary page 1.
- K990092: Avl Omni Modular Analyzer, Avl Scientific Corp. (1999) Summary page 1.
- K954482: Sendx 100 PH, Blood Gas & Electrolyte Analysis System, Cirrus Medical,Inc. (1995) Summary page 1.
- K981270: Irma Blood Analysis System, Diametrics Medical, Inc. (1998) Summary page 1.
- K940918: I-Stat 200 Portable Clinical Analyzer, I-Stat Corp. (1994) Summary page 1.
- K972673: Avl 9181 Electrolyte Analyzer, Avl Scientific Corp. (1997). Our OCR of the scanned summary read K972763, FDA’s number for Hemaprompt (Aerscher Diagnostics). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “AVL 9181”.
- K823480: IL 943 Flame Photometer, Instrumentation Laboratory CO (1983) Summary page 1.
- K944089: Avl Opti PH/Blood Gas Analyzer, Avl Scientific Corp. (1994) Summary page 1.
- K961161: Avl Opti 1 PH/Blood Gas Analyzer, Avl Scientific Corp. (1996) Summary page 1.
- K974784: Avl Opti Critical Care Analyzer, Avl Scientific Corp. (1998) Summary page 1.
- K984299: Avl Opti Critical Care Analyzer, Avl Scientific Corp. (1998) Summary page 1.

## Most influential descendants
- 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 Critical Care Analyzer intended to be used for the measurement of pH, PCO,, PO,, ctHb, SO,, Na’, K*, CI', Ca™", glucose and BUN in whole blood, serum, plasma and aqueous dialysate solutions as appropriate by minimally trained personnel qualified to perform and to report these values in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.

Source page: https://510kreport.com/device/K993837
Methodology: https://510kreport.com/methodology