Cleared Traditional

COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS (K945371) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 118
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K945371.
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · Baxter Healthcare Corp · Dec 1994
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · Baxter Healthcare Corp · May 1993