Cleared Traditional

K150151 - SmartGownTM surgical gown

K150151 is an FDA 510(k) clearance for SmartGownTM surgical gown, manufactured by Cardinal Health 200, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K150151 · Cardinal Health 200, Inc. · General Hospital
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May 2015
Decision
118d
Days
Class 2
Risk

K150151 is an FDA 510(k) clearance for the SmartGownTM surgical gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Cardinal Health 200, Inc. (Waukegan, US). The FDA issued a Cleared decision on May 21, 2015 after a review of 118 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 Cardinal Health 200, Inc. devices

FDA 510(k) Submission Details - K150151

510(k) Number K150151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2015
Decision Date May 21, 2015
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 166
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K150151.
Medline Prevention CoolZone Gown
K172954 · Medline Industries, Inc. · Jun 2018
Cardinal Health Non-Reinforced Surgical Gown
K170762 · Cardinal Health200, LLC · Jun 2017
Blockade Surgical Gown
K150598 · Medline Industries, Inc. · Apr 2016
TOTAL SHIELD SURGICAL
K142166 · Zimmer, Inc. · Aug 2014
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · Stryker Corporation · Aug 2014
T4/T5 HYTREL TOGAS
K121664 · Stryker Corporation · Mar 2014