Cleared Traditional

K851938 - OMNIMED SURGICAL GOWN

K851938 is an FDA 510(k) clearance for OMNIMED SURGICAL GOWN, manufactured by Omni Intl., Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K851938 · Omni Intl., Inc. · General Hospital
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Jun 1985
Decision
56d
Days
Class 2
Risk

K851938 is an FDA 510(k) clearance for the OMNIMED SURGICAL GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Omni Intl., Inc. (Palm Springs, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Omni Intl., Inc. devices

FDA 510(k) Submission Details - K851938

510(k) Number K851938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1985
Decision Date June 28, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 129d · This submission: 56d
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 182
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K851938.
THEATRE GOWNS
K872758 · Smith & Nephew, Inc. · Jul 1987
SPUNGUARD PLUS SURGICAL GOWN
K861600 · Kimberly-Clark Corp. · May 1986
BARRIER SURGICAL GOWN
K852870 · Surgikos, Inc. · Jul 1985
TURQUOISE
K851559 · Roseburg SA · Apr 1985
BOUNDARY SINGLE-USE OR GOWN
K842958 · Procter & Gamble Mfg. Co. · Aug 1984
BOUNDARY SINGLE-USE GOWNS
K834332 · Procter & Gamble Mfg. Co. · May 1984