# K011670: Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with Trutrak+Motion Correction Performance

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda
- Decided: Jun 26, 2001 after 27 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010463 (2001). 1 ancestor in all.
30 later devices descend from it; 2 cite it directly.
4 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010463: Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires, Datex-Ohmeda, Inc. (2001) Summary page 2.

## Most influential descendants
- K021955: Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & Accessories (2002), 28 descendants of its own
- K040831: Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 (2004), 27 descendants of its own
- K073203: Carescape V100 (2007), 20 descendants of its own
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own

## Recalls of this device
- Sep 16, 2002 · Not classified · Z-0610-03: Falsely high blood oxygen saturation readings in some circumstances could result in no alarm in a critical life-threatening situation.

## Indications for use
The Datex-Ohmeda S/5™ Oxygen Saturation Module, M-OSAT, and accessories are indicated for monitoring arterial oxygen saturation of hospitalized patients including monitoring during conditions of clinical patient motion. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K011670
Methodology: https://510kreport.com/methodology