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
K110398Substantially Equivalent

Respironics Disposable Heated Wire Circuits

Respironics, Inc., Murrysville PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110398 is the FDA 510(k) clearance record for RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS, a class II device, cleared for Respironics, Inc. on under FDA product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer). FDA records list 186 510(k) clearances for Respironics, Inc., from to . As of , FDA records show no recalls naming K110398.

Clearance record

Decision date
Received
(110 days to decision)
Product code
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation
21 CFR 868.5270
Device class
Class II
Review panel
Anesthesiology
Applicant
Respironics, Inc. 1740 Golden Mile Hwy., Murrysville PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZE

Trailing 12 months
2 clearances under product code BZE in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260