Cleared Traditional

K043004 - STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031

K043004 is an FDA 510(k) clearance for STACKHOUSE FREEDOMAIRE II SURGICAL HELM..., manufactured by Viasys Medsystems. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K043004 · Viasys Medsystems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
135d
Days
Class 2
Risk

K043004 is an FDA 510(k) clearance for the STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011,.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Viasys Medsystems (Wheeling, US). The FDA issued a Cleared decision on March 16, 2005 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K043004

510(k) Number K043004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2004
Decision Date March 16, 2005
Days to Decision 135 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 129d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 259
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K043004.
COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS
K041540 · Standard Textile Co., Inc. · May 2005
COMPEL SURGICAL GOWNS
K041539 · Standard Textile Co., Inc. · Apr 2005
COMPEL MLR SURGICAL GOWNS
K041541 · Standard Textile Co., Inc. · Mar 2005
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005
MEDLINE SURGICAL GOWNS
K043585 · Medline Industries, Inc. · Mar 2005
PROMEDICAL SURGICAL GOWNS
K042111 · Promedical Products Co., Ltd. · Dec 2004