# K020479: Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, M-Nsat and Accessories

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Mar 26, 2002 after 41 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: 1 generation back to K943456 (1994). 1 ancestor in all.
2 later devices descend 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)
- K943456: AS/3 Nellcor Compatible Saturation Moodule, M-Nsat, Datex Division Instrumentarium Corp. (1994) Summary page 1.

## Most influential descendants
- K052755: Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat (2005), 1 descendant of its own
- K081870: Masimo Compatible Saturation Module, E-Masimo (2008), 0 descendants of its own

## Indications for use
The Datex-Ohmeda S/5™ Nellcor Compatible Saturation Module, M-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/K020479
Methodology: https://510kreport.com/methodology