Cleared Traditional

K945371 - COMPEL 3000 SURGICAL GOWN

K945371 is an FDA 510(k) clearance for COMPEL 3000 SURGICAL GOWN, manufactured by Standard Textile Co., Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K945371 · Standard Textile Co., Inc. · General Hospital
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Apr 1995
Decision
176d
Days
Class 2
Risk

K945371 is an FDA 510(k) clearance for the COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 176 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 Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K945371

510(k) Number K945371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date April 27, 1995
Days to Decision 176 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 129d · This submission: 176d
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 167
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K945371.
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
OREX SURGEON'S VEST
K961083 · Thantex Specialties, Inc. · Aug 1996
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · Standard Textile Co., Inc. · Apr 1995
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995
OREX SURGEON'S GOWN
K944827 · Thantex Specialties, Inc. · Feb 1995