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

Calibrator, Pressure, Gas

21 CFR 868.2620 / Anesthesiology
FDA source (opens on fda.gov)

BXX is the FDA product code for Calibrator, Pressure, Gas, a class I device type, regulated under 21 CFR 868.2620. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
BXX
Device name
Calibrator, Pressure, Gas
Regulation
21 CFR 868.2620
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
10
Ingested recalls
0

Clearances, product code BXX

By decision year
10 clearances under product code BXX with a decision year between 1978 and 1992, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BXX by decision year
YearClearances
19782
19791
19803
19821
19851
19881
19921

Applicants with the most clearances

Product code BXX
Applicants holding the most 510(k) clearances under product code BXX
ApplicantClearances
Kleen Test Products Corporation3
Timeter Instrument Corp.2
Equilibrated Bio Systems, Inc.1
Escalon Medical Trek1
Micro Tronics Corp.1
Pennwalt Corp.1
Utah Medical Products, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code