Cleared Traditional

K043004 - STACKHOUSE FREEDOMAIRE II SURGICAL HELM...

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
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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.

View all Viasys Medsystems devices

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
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 168
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K043004.
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