# K922075: Avoximeter

- Pathway: 510(k) (Traditional)
- Applicant: A-Vox Systems, Inc.
- Decided: Nov 4, 1992 after 184 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 3 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 27, 2024 · Class II · Z-0279-2025: Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, whic
- Feb 13, 2008 · Not classified · Z-1237-2008: Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
- Feb 13, 2008 · Not classified · Z-1238-2008: Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.

Source page: https://510kreport.com/device/K922075
Methodology: https://510kreport.com/methodology