# K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

- Pathway: 510(k) (Traditional)
- Applicant: Faceheart Corp.
- Decided: Apr 9, 2025 after 107 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913396 (1992). 50 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242001: Philips VSC-MEDlib, Philips Medical Systems Nederland B.V. (2025). Cleared while this submission was under review Summary page 7.

## Most influential descendants
- K253650: Anura Mobile Core SDK (M1) (2026), 0 descendants of its own

## Indications for use
FH Vitals SDK-RR is a software-only respiratory rate measurement tool intended to be integrated into third-party software applications on compatible mobile devices, laptops, or computers. It is intended for spot checking of Respiration Rate (RR) in an automatic contactless manner by analyzing chest wall movement from video input when the subject is still and properly positioned in front of the camera in a well-lit environment. FH Vitals SDK-RR is intended for use under the supervision of a healthcare professional, either in clinical or home environments, and is not intended for continuous monitoring, apnea detection, or as the sole method for evaluating physical health. It is intended to serve as a supplemental tool to assist in the overall assessment of the patient. The software is indicated for use on individuals aged 18 years and older who do not require critical care or continuous vital sign monitoring.

Source page: https://510kreport.com/device/K243966
Methodology: https://510kreport.com/methodology