# Faceheart Corp.

- Location (FDA's records): Grand Cayman, KY
- FDA decisions: 2 (2023–2025): 2 510(k) clearances
- Product codes: QME (1), BZQ (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Oxehealth Limited: 1 (https://510kreport.com/company/oxehealth)
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)

## Firms that cite its devices most
- Nuralogix Corporation: 2 (https://510kreport.com/company/nuralogix)

## Its most-cited devices
- K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK) (2023), cited by 1
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (2025), cited by 1

## Recent decisions
- K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (Apr 9, 2025)
- K223622: FaceHeart Vitals Software Development Kit (FH vitals SDK) (Sep 1, 2023)

Source page: https://510kreport.com/company/faceheart