Cleared Traditional

K153255 - Aero Chrome* Breathable Performance Sur...

K153255 is an FDA 510(k) clearance for Aero Chrome* Breathable Performance Sur..., manufactured by Halyard Health, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K153255 · Halyard Health, Inc. · General Hospital
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Apr 2016
Decision
155d
Days
Class 2
Risk

K153255 is an FDA 510(k) clearance for the Aero Chrome* Breathable Performance Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Halyard Health, Inc. (Alpharetta, US). The FDA issued a Cleared decision on April 13, 2016 after a review of 155 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 Halyard Health, Inc. devices

FDA 510(k) Submission Details - K153255

510(k) Number K153255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2015
Decision Date April 13, 2016
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 160
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