510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962766Substantially Equivalent

Airsep Impulse

Airsep Corp., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962766 is the FDA 510(k) clearance record for AIRSEP IMPULSE, a class II device, cleared for Airsep Corp. on under FDA product code NFB (Conserver, Oxygen). FDA records list 19 510(k) clearances for Airsep Corp., from to . As of , FDA records show no recalls naming K962766.

Clearance record

Decision date
Received
(86 days to decision)
Product code
NFB Conserver, Oxygen
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Airsep Corp. 290 Creekside Dr., Buffalo NY
510(k) summary
Statement
Third party review
No

Clearances, product code NFB

Trailing 12 months

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

FDA records show no clearances under product code NFB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NFB, 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