510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915226Substantially Equivalent

Isothermal Heated Ventilator & Anesthesia Circuit

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915226 is the FDA 510(k) clearance record for ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT, a class II device, cleared for Baxter Healthcare Corp on under FDA product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show 4 recalls naming K915226.

Clearance record

Decision date
Received
(419 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
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
510(k) summary
Summary
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