# K123217: Cardeascreen

- Pathway: 510(k) (Traditional)
- Applicant: Cardea Associates, Inc.
- Decided: Feb 5, 2013 after 113 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921669 (1993). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093211: Carecenter MD, Cardiac Science Corporation (2010) Summary page 2.
- K103640: Midmark Iqecg, Brentwood Medical Technology Corp. (2011) Summary page 2.

## Indications for use
Cardeacreen records and measures a resting ECG from the adult and pediatric (age : 14) body surface. It provides automatic ECG interpretations which are identified as "Unconfirmed" by the product until they have been over-read and confirmed by a clinician. Cardeacreen is intended for use on apparently healthy individuals and on symptomatically stable patients with known or potential cardiac conditions. This device is intended for use under the direct supervision of a licensed health care clinician.

Source page: https://510kreport.com/device/K123217
Methodology: https://510kreport.com/methodology