510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043004Substantially Equivalent

Stackhouse Freedomaire II Surgical Helmet System, Models 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031

Viasys Medsystems, Wheeling IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K043004 is the FDA 510(k) clearance record for STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031, a class II device, cleared for Viasys Medsystems on under FDA product code FYA (Gown, Surgical). FDA records list 7 510(k) clearances for Viasys Medsystems, from to . As of , FDA records show no recalls naming K043004.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Viasys Medsystems 100 Chaddick Dr., Wheeling IL
510(k) summary
Statement
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