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
BZDClass II

Ventilator, Non-Continuous (Respirator)

21 CFR 868.5905 / Anesthesiology
FDA source (opens on fda.gov)

BZD is the FDA product code for Ventilator, Non-Continuous (Respirator), a class II device type, regulated under 21 CFR 868.5905. As of , FDA records hold 461 510(k) clearances under this code, the most recent dated , and 81 recalls.

Classification record

Product code
BZD
Device name
Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
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
No
Ingested clearances
462
Ingested recalls
83

Clearances, product code BZD

By decision year
462 clearances under product code BZD with a decision year between 1977 and 2026, 2004 the highest year at 30.
Show the numbers
510(k) clearances under FDA product code BZD by decision year
YearClearances
19771
19801
19812
19831
19841
19852
19864
19873
19891
199111
19921
19933
19948
19954
199619
19978
199810
199914
200012
200110
200215
200321
200430
200523
200617
200721
200817
200923
201012
201123
201221
201323
201414
201511
201612
20175
20185
20196
20206
20216
20224
20235
202410
20257
20269

Applicants with the most clearances

Product code BZD
Applicants holding the most 510(k) clearances under product code BZD
ApplicantClearances
ResMed Corp97
Respironics, Inc.68
Fisher & Paykel Healthcare, Inc.31
SleepNet Corporation18
Apex Medical, Inc.12
Medtronic, Inc.12
Respironics Inc., Sleep & Home Respiratory Group10
Sunrise Medical, Inc.10
3B Medical Inc9
Weinmann Gerate Fur Medizin GmbH + Co. KG9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 101 companies shown, in name order