510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942434Substantially Equivalent

Bionaire Clear Air Air Purifier & Ionizer

Bionaire Corp., Lachine, Quebec, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942434 is the FDA 510(k) clearance record for BIONAIRE CLEAR AIR AIR PURIFIER & IONIZER, a class II device, cleared for Bionaire Corp. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list 2 510(k) clearances for Bionaire Corp., from to . As of , FDA records show no recalls naming K942434.

Clearance record

Decision date
Received
(208 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Bionaire Corp. 2000-32nd Ave., Lachine, Quebec, CA
510(k) summary
Summary
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