# K141362: Pulse Oximeter CMS50EW

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: Apr 23, 2015 after 335 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: 15 generations back to K941811 (1994). 104 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090671: Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60D, Contec Medical System Co., Ltd. (2009) Summary page 5.

## Most influential descendants
- K172141: Pulse Oximeter (2018), 0 descendants of its own

## Indications for use
The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.

Source page: https://510kreport.com/device/K141362
Methodology: https://510kreport.com/methodology