Cleared Traditional

K926519 - SURGICAL GOWN

K926519 is an FDA 510(k) clearance for SURGICAL GOWN, manufactured by Custom Medical Products, Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K926519 · Custom Medical Products, Ltd. · General Hospital
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Aug 1993
Decision
225d
Days
Class 2
Risk

K926519 is an FDA 510(k) clearance for the SURGICAL GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Custom Medical Products, Ltd. (Asheville, US). The FDA issued a Cleared decision on August 12, 1993 after a review of 225 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 Custom Medical Products, Ltd. devices

FDA 510(k) Submission Details - K926519

510(k) Number K926519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1992
Decision Date August 12, 1993
Days to Decision 225 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
96d slower than avg
Panel avg: 129d · This submission: 225d
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 150
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K926519.
HYDRAGOWN
K934664 · Mallinckrodt Group, Inc. · May 1994
BARRIER FABRIC 450 SURGICAL GOWN
K934608 · Johnson & Johnson Medical, Inc. · Apr 1994
3M PREVENTION FABRIC SURGICAL GOWN #78XX
K930681 · 3M Health Care, Ltd. · Feb 1994
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · Baxter Healthcare Corp · May 1993
BARRIER SURGICAL GOWN WITH SYMETRY FABRIC
K920996 · Johnson & Johnson Medical, Inc. · May 1992
STERILE CONVERTOR SAFECARE GOWN AND DRAPE
K920837 · Baxter Healthcare Corp · May 1992