# K990092: Avl Omni Modular Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Jan 29, 1999 after 18 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K940918 (1994). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960120: Stat Profile Ultra F,G,H,I,J, and K Analyzers, Nova Biomedical Corp. (1996) Summary page 1.
- K940918: I-Stat 200 Portable Clinical Analyzer, I-Stat Corp. (1994) Summary page 1.
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer, Boehringer Mannheim Corp. (1995) Summary page 1.

## Most influential descendants
- K013373: Omni C Analyzer (2001), 2 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
- K032311: Roche Diagnostics Omni S Analyzer (2003), 1 descendant of its own
- K200986: OPTI® B-Lac Cassette (2021), 0 descendants of its own

## Recalls of this device
- Dec 29, 2003 · Not classified · Z-0336-04: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Dec 29, 2003 · Not classified · Z-0335-04: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Dec 29, 2003 · Not classified · Z-0337-04: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
- Dec 16, 2002 · Not classified · Z-0438-03: Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.

## Indications for use
The AVL OMNI™ is a modular Critical Care Analyzer intended to be used for the measurement of pH, PCO,, PO,, ctHb, HHb, O,Hb, COHb, MetHb, SulfHb, Na’, K’, CI', ionized Ca"’, Hematocrit, glucose, lactate and urea nitrogen in whole blood, serum, plasma, dialysate and QC materials as appropriate by minimally trained personnel qualified to perform and to report these values in a clinical laboratory setting.

Source page: https://510kreport.com/device/K990092
Methodology: https://510kreport.com/methodology