FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
by Faceheart Corp. 510(k)
Active
510(k) K243966
Overview
The device 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 a Class II Software as a Medical Device (SaMD) that provides contactless vital sign measurement using video-based technology.
It is supplied as a software development kit for integration into third-party applications. The device has received FDA 510(k) clearance (K243966) and is classified under product code BZQ with regulation number 868.2375. It is used in real-world environments for monitoring respiratory rate as part of vital sign assessment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK243966 | Date9 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Faceheart Corp.
Questions
What is the FaceHeart Vitals SDK-RR intended for?
The FaceHeart Vitals SDK-RR is intended to measure respiratory rate as part of vital sign assessment using contactless video-based technology. It is designed to be integrated into third-party software applications running on compatible mobile devices, laptops, or computers for real-world monitoring.
How is the FaceHeart Vitals SDK-RR supplied and used?
The device is supplied as a software development kit (SDK) for integration into third-party applications. It is a software-only product that enables contactless respiratory rate measurement when embedded in host software running on supported hardware platforms.
Is the FaceHeart Vitals SDK-RR a single-use or reusable device?
As a software-only medical device, the FaceHeart Vitals SDK-RR does not have physical components that are used or consumed. It can be used repeatedly as part of the host application without degradation, subject to the terms of the software license and continued compatibility with the host system.
What regulatory pathway was used for the FaceHeart Vitals SDK-RR?
The FaceHeart Vitals SDK-RR received FDA 510(k) clearance under submission number K243966. It was found substantially equivalent to a predicate device and is classified as a Class II Software as a Medical Device (SaMD) under product code BZQ and regulation 868.2375.