# K081870: Masimo Compatible Saturation Module, E-Masimo

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare Finland Oy
- Decided: Jul 31, 2008 after 30 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: 3 generations back to K943456 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052755: Datex-Ohmeda S/5 Nellcor Compatible Saturation Module, E-Nsat, GE Healthcare (2005) Summary page 1.

## Indications for use
The Masimo Compatible Saturation Module, E-MASIMO, and accessories are indicated for monitoring arterial oxygen saturation and pulse rate of hospitalized patients. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K081870
Methodology: https://510kreport.com/methodology