Cleared Abbreviated

K210688 - AERO CHROME* Select Breathable Performa...

K210688 is the FDA 510(k) clearance for AERO CHROME* Select Breathable Performa... by O&M Halyard, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Abbreviated 510(k) pathway after a 135-day FDA review.

K210688 · O&M Halyard, Inc. · General Hospital
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Jul 2021
Decision
135d
Days
Class 2
Risk

K210688 is an FDA 510(k) clearance for the AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on July 21, 2021 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all O&M Halyard, Inc. devices

Submission Details

510(k) Number K210688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2021
Decision Date July 21, 2021
Days to Decision 135 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
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
Standards-based clearance path.

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 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K210688.
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