Cleared Traditional

K780853 - OP-SITE ADHESIVE DRAPES

K780853 is the FDA 510(k) clearance for OP-SITE ADHESIVE DRAPES by Acme United Corp.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K780853 · Acme United Corp. · General Hospital
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Aug 1978
Decision
84d
Days
Class 2
Risk

K780853 is an FDA 510(k) clearance for the OP-SITE ADHESIVE DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Acme United Corp. devices

Submission Details

510(k) Number K780853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1978
Decision Date August 14, 1978
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 162
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K780853.
BARRIER BASIC PACK FABRIC 450
K780842 · Surgikos, Inc. · Aug 1978
BARRIER ABDOMINAL PACK FABRIC 450
K780843 · Surgikos, Inc. · Aug 1978
BARRIER OBSTETRICAL PACK FABRIC 450
K780844 · Surgikos, Inc. · Aug 1978
BARRIER GYNECOLOGY PACK FABRIC 450
K780856 · Surgikos, Inc. · Aug 1978
DRAPING MATERIAL, COLBALT 60 STERILE
K780846 · Kimberly-Clark Corp. · Jun 1978
LEAD HAND
K772387 · Edward Weck, Inc. · Apr 1978