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

Warmer, Blood, Non-Electromagnetic Radiation

21 CFR 864.9205 / Hematology
FDA source (opens on fda.gov)

BSB is the FDA product code for Warmer, Blood, Non-Electromagnetic Radiation, a class II device type, regulated under 21 CFR 864.9205. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
BSB
Device name
Warmer, Blood, Non-Electromagnetic Radiation
Regulation
21 CFR 864.9205
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
2

Clearances, product code BSB

By decision year
14 clearances under product code BSB with a decision year between 1976 and 2011, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BSB by decision year
YearClearances
19761
19771
19961
19981
19993
20011
20021
20031
20051
20061
20091
20111

Applicants with the most clearances

Product code BSB
Applicants holding the most 510(k) clearances under product code BSB
ApplicantClearances
Belmont Medical Technologies5
Estill Medical Technologies, Inc2
Stihler Electronic GmbH2
Augustine Medical, Inc.1
Baxter Healthcare Corporation1
Gorman Rupp Industries1
Nats Corp.1
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order