Cleared Traditional

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

K243966 · Faceheart Corp. · Anesthesiology

Apr 2025

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K243966 is an FDA 510(k) clearance for the FaceHeart Vitals Software Development Kit (FH vitals SDK-RR), a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Faceheart Corp. (Grand Cayman, KY). The FDA issued a Cleared decision on April 9, 2025, 107 days after receiving the submission on December 23, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number	K243966 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	April 09, 2025
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF