# K253436: c-med0 alpha

- Pathway: 510(k) (Traditional)
- Applicant: Cosinuss GmbH
- Decided: Apr 30, 2026 after 211 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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). 149 ancestors in all.
No later device cites it as a predicate yet.
1 of 150 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212975: MedWand, Medwand Solutions, Inc. (2022) Summary page 9.
- K170047: All-in-One Health Monitor, PC-303, Shenzhen Creative Industry Co., Ltd. (2017) Summary page 9.

## Indications for use
The medical purpose of the c-med 0 alpha device is a non-invasive measurement of body temperature (TEMP), blood oxygen saturation (Sp02) and Pulse Rate (PR). In combination with the c-med 0 software applications the system is indicated for spot-checking and/or continuous data collection of adults during non-motion conditions in hospitals, medical facilities and home healthcare environments. The system is intended for spot checking, meaning the sensor device can be worn continuously, but the user must actively start and open the App whenever they intend to check or collect manually the measurement data.

Source page: https://510kreport.com/device/K253436
Methodology: https://510kreport.com/methodology