510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243966Substantially Equivalent

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

Faceheart Corp., Grand Cayman, KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243966 is the FDA 510(k) clearance record for FaceHeart Vitals Software Development Kit (FH vitals SDK-RR), a class II device, cleared for Faceheart Corp. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 2 510(k) clearances for Faceheart Corp., from to . As of , FDA records show no recalls naming K243966.

Clearance record

Decision date
Received
(107 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Faceheart Corp. P.O. Box 309, Ugland House, Grand Cayman, KY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260