510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864261Substantially Equivalent

Model 3500 Infant Respiration & Heart Rate Monitor

Bio-Dyne, Inc., Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864261 is the FDA 510(k) clearance record for MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR, a class II device, cleared for Bio-Dyne, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list 3 510(k) clearances for Bio-Dyne, Inc., from to . As of , FDA records show no recalls naming K864261.

Clearance record

Decision date
Received
(149 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Bio-Dyne, Inc. 36 Higgins Dr., Milford CT
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