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

Mask, Gas, Anesthetic

21 CFR 868.5550 / Anesthesiology
FDA source (opens on fda.gov)

BSJ is the FDA product code for Mask, Gas, Anesthetic, a class I device type, regulated under 21 CFR 868.5550. As of , FDA records hold 51 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
BSJ
Device name
Mask, Gas, Anesthetic
Regulation
21 CFR 868.5550
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
51
Ingested recalls
1

Clearances, product code BSJ

By decision year
51 clearances under product code BSJ with a decision year between 1979 and 2017, 1984 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code BSJ by decision year
YearClearances
19792
19801
19812
19821
19832
19849
19853
19865
19873
19885
19894
19902
19921
19932
19942
19956
20171

Applicants with the most clearances

Product code BSJ
Applicants holding the most 510(k) clearances under product code BSJ
ApplicantClearances
Medipart Jerry Alexander6
Life Design Systems, Inc.3
Vital Signs, Inc.3
Engineered Medical Systems, LLC2
Hans Rudolph, Inc.2
Ohio Medical Products2
Rondex Products, Inc.2
Warne Surgical Products, Ltd.2
Advanced Warming Systems, Inc.1
Ambu, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 156 companies shown, in name order