510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942683Substantially Equivalent

Bionaire Hepa Air Purifiers /Sh-1240, 1260, 1840, 1860, Ch-3550

Bionaire Corp., Lachine H8t 3h7, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942683 is the FDA 510(k) clearance record for BIONAIRE HEPA AIR PURIFIERS /SH-1240, 1260, 1840, 1860, CH-3550, 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 K942683.

Clearance record

Decision date
Received
(174 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 H8t 3h7, 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