510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130702Substantially Equivalent

Airsonett Air-4

Airsonett AB, Fridley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130702 is the FDA 510(k) clearance record for AIRSONETT AIR-4, a class II device, cleared for Airsonett AB on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list 2 510(k) clearances for Airsonett AB, from to . As of , FDA records show no recalls naming K130702.

Clearance record

Decision date
Received
(130 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Airsonett AB 435 Rice Creek Ter. NE, Fridley MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRF

Trailing 12 months
1 clearance under product code FRF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260