# K173248: Cardioskin

- Pathway: 510(k) (Traditional)
- Applicant: Bioserenity Sas
- Decided: Aug 11, 2018 after 305 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K882803 (1988). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161431: SimplECG, Nanowear, Inc. (2016) Summary page 4.
- K142476: Master Caution Device MCD, Healthwatch, Ltd. (2015) Summary page 4.

## Indications for use
Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.

Source page: https://510kreport.com/device/K173248
Methodology: https://510kreport.com/methodology