# K052755: Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Oct 13, 2005 after 13 days
- Product code: DQA (Oximeter)
- 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: 2 generations back to K943456 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020479: Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and Accessories, Datex-Ohmeda (2002) Summary page 2.

## Most influential descendants
- K081870: Masimo Compatible Saturation Module, E-Masimo (2008), 0 descendants of its own

## Indications for use
The Datex-Ohmeda S/5 Tm Nellcor Compatible Saturation Module, E-NSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K052755
Methodology: https://510kreport.com/methodology