# K951485: Avoximeter 4000

- Pathway: 510(k) (Traditional)
- Applicant: A-Vox Systems, Inc.
- Decided: Nov 6, 1995 after 221 days
- Product code: JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide)
- Device class: 1
- Regulation: 21 CFR 862.3220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K050014: Hemonir TM (2005), 0 descendants of its own

## Recalls of this device
- Mar 23, 2011 · Not classified · Z-2218-2011: An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.
- Feb 13, 2008 · Not classified · Z-1239-2008: 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/K951485
Methodology: https://510kreport.com/methodology