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

Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

21 CFR 868.5270 / Anesthesiology
FDA source (opens on fda.gov)

BZE is the FDA product code for Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, a class II device type, regulated under 21 CFR 868.5270. As of , FDA records hold 46 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
BZE
Device name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Regulation
21 CFR 868.5270
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
46
Ingested recalls
7

Clearances, product code BZE

By decision year
46 clearances under product code BZE with a decision year between 1976 and 2026, 1988 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code BZE by decision year
YearClearances
19761
19771
19782
19801
19821
19841
19852
19861
19886
19902
19932
19972
19991
20001
20051
20102
20111
20122
20141
20151
20165
20171
20181
20211
20231
20242
20251
20262

Applicants with the most clearances

Product code BZE
Applicants holding the most 510(k) clearances under product code BZE
ApplicantClearances
Fisher & Paykel Healthcare, Inc.3
Medtronic, Inc.2
Applinc2
CareFusion 303, Inc2
Flexicare Medical Ltd.2
MEDLINE INDUSTRIES, LP - Northfield2
Plastiflex Group NV2
Respironics, Inc.2
Advanced Research Technologies, Inc.1
Armour Pharmaceutical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 41 companies shown, in name order