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

Spirometer, Monitoring (W/Wo Alarm)

21 CFR 868.1850 / Anesthesiology
FDA source (opens on fda.gov)

BZK is the FDA product code for Spirometer, Monitoring (W/Wo Alarm), a class II device type, regulated under 21 CFR 868.1850. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
BZK
Device name
Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
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
62
Ingested recalls
3

Clearances, product code BZK

By decision year
62 clearances under product code BZK with a decision year between 1976 and 2026, 1983 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code BZK by decision year
YearClearances
19761
19771
19782
19793
19801
19811
19823
19837
19846
19852
19864
19872
19881
19895
19902
19911
19921
19932
19971
19981
20051
20061
20081
20093
20111
20121
20131
20171
20182
20192
20261

Applicants with the most clearances

Product code BZK
Applicants holding the most 510(k) clearances under product code BZK
ApplicantClearances
Respitrace Corp.6
Respiratory Motion, Inc.5
Bear Medical Systems, Inc.4
GE Healthcare4
Respironics Novametrix, LLC.4
Boehringer Laboratories, LLC3
Ohio Medical Products3
Cairco, Ltd.2
Cybermedic, Inc.2
Empire Plastics Manufacturer2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order