# K050014: Hemonir TM

- Pathway: 510(k) (Traditional)
- Applicant: Nir Diagnostics, Inc.
- Decided: May 5, 2005 after 122 days
- Product code: GLY (Oximeter To Measure Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853990 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853990: OSM3 Hemoximeter, Radiometer America, Inc. (1985) Summary page 1.
- K951485: Avoximeter 4000, A-Vox Systems, Inc. (1995) Summary page 1.

## Indications for use
HemoNIRLbTM is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methemoglobin and carboxyhemoglobin.

Source page: https://510kreport.com/device/K050014
Methodology: https://510kreport.com/methodology