510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040485Substantially Equivalent

Maxair Surgical Helmet System

Bio-Medical Devices, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040485 is the FDA 510(k) clearance record for MAXAIR SURGICAL HELMET SYSTEM, a class II device, cleared for Bio-Medical Devices, Inc. on under FDA product code FYA (Gown, Surgical). FDA records list 7 510(k) clearances for Bio-Medical Devices, Inc., from to . As of , FDA records show one recall naming K040485.

Clearance record

Decision date
Received
(236 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bio-Medical Devices, Inc. 17171 Daimler Ave., Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260