# K042891: Datex-Ohmeda Oxy-Afr Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda
- Decided: Jun 29, 2005 after 253 days
- Product code: NLF (Oximeter, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010463 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021265: Datex-Ohmeda Hmef 500, Datex-Ohmeda (2002) Summary page 2.
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500, Datex-Ohmeda, Inc. (2004) Summary page 3.

## Indications for use
The reprocessed AliFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K042891
Methodology: https://510kreport.com/methodology