FDA 510(k) · FaceHeart
K243966: FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (Faceheart Corp.)
Faceheart Corp. received FDA 510(k) K243966 for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR), with a decision date of Apr 9, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K243966 |
|---|---|
| Pathway | 510(k) |
| Applicant | Faceheart Corp. |
| Device name | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) |
| Product code | BZQ: Monitor, Breathing Frequency |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Dec 23, 2024 |
| Decision date | Apr 9, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K243966
- K253650 Anura Mobile Core SDK (M1) (Nuralogix, Jun 11, 2026, QME)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code BZQ is "Monitor, Breathing Frequency", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Other, sensor Other. These are heuristics, not FDA fields.