# K070421: Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Mar 13, 2007 after 28 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 3 generations back to K935477 (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)
- K051634: Datex-Ohmeda S/5 Device Interfacing Solution, GE Healthcare (2005) Summary page 1.

## Recalls of this device
- May 8, 2009 · Not classified · Z-1558-2009: GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monito

## Indications for use
The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01 with N-DISVENT..02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K070421
Methodology: https://510kreport.com/methodology