Cleared Traditional

K190306 - AMD Ritmed AssureWear VersaGown

K190306 is an FDA 510(k) clearance for AMD Ritmed AssureWear VersaGown, manufactured by Amd Medicom, Inc.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K190306 · Amd Medicom, Inc. · General Hospital
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Jan 2020
Decision
339d
Days
Class 2
Risk

K190306 is an FDA 510(k) clearance for the AMD Ritmed AssureWear VersaGown. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Amd Medicom, Inc. (Pointe-Claire, Montreal, CA). The FDA issued a Cleared decision on January 17, 2020 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Amd Medicom, Inc. devices

FDA 510(k) Submission Details - K190306

510(k) Number K190306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2019
Decision Date January 17, 2020
Days to Decision 339 days
Submission Type Traditional
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
210d slower than avg
Panel avg: 129d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K190306.
ComfortGuard Surgical Isolation Gown
K210131 · Gri-Alleset, Inc. · Aug 2021
Surgical Isolation Gown
K203415 · Yanbian Pacific Textile Co., Ltd. · May 2021
Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
K202310 · Wildcat Ppe, LLC · Jan 2021
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018
Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016