# K954018: Avl Omni Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Avl Scientific Corp.
- Decided: Oct 5, 1995 after 41 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Dec 29, 2003 · Not classified · Z-0330-04: 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-0331-04: 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-0333-04: 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-0334-04: 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-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-0332-04: 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.

Source page: https://510kreport.com/device/K954018
Methodology: https://510kreport.com/methodology