Cleared Traditional

MAXAIR SURGICAL HELMET SYSTEM (K040485) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040485 · Bio-Medical Devices, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 2004
Decision
236d
Days
Class 2
Risk

K040485 is an FDA 510(k) clearance for the MAXAIR SURGICAL HELMET SYSTEM. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Bio-Medical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on October 18, 2004 after a review of 236 days - an extended review cycle.

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 Bio-Medical Devices, Inc. devices

Submission Details

510(k) Number K040485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2004
Decision Date October 18, 2004
Days to Decision 236 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 129d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K040485.
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005
MEDLINE SURGICAL GOWNS
K043585 · Medline Industries, Inc. · Mar 2005
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · Biomet, Inc. · Jan 2003
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · Medline Industries, Inc. · Feb 2001