510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921313Substantially Equivalent

Aerostar

Biosafety Systems, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921313 is the FDA 510(k) clearance record for AEROSTAR, a class II device, cleared for Biosafety Systems, Inc. on under FDA product code CBN (Apparatus, Gas-Scavenging). FDA records list 8 510(k) clearances for Biosafety Systems, Inc., from to . As of , FDA records show no recalls naming K921313.

Clearance record

Decision date
Received
(177 days to decision)
Product code
CBN Apparatus, Gas-Scavenging
Regulation
21 CFR 868.5430
Device class
Class II
Review panel
Anesthesiology
Applicant
Biosafety Systems, Inc. 8380 Camino Santa Fe, San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code CBN

Trailing 12 months

FDA records hold no clearances under product code CBN in the trailing twelve months.

FDA records show no clearances under product code CBN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260