Cleared Traditional

K872757 - OPSITE SPECIALITY DRAPES

K872757 is the FDA 510(k) clearance for OPSITE SPECIALITY DRAPES by Smith & Nephew, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K872757 · Smith & Nephew, Inc. · General Hospital
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Jul 1987
Decision
15d
Days
Class 2
Risk

K872757 is an FDA 510(k) clearance for the OPSITE SPECIALITY DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on July 28, 1987 after a review of 15 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K872757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1987
Decision Date July 28, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
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 149
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K872757.
AM TM SYRGICAL DRAPES
K882643 · Henley Intl. · Mar 1989
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086 · 3M Company · Dec 1987
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987
MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY
K864388 · Deroyal Industries, Inc. · Feb 1987
SPUNGUARD PLUS SURGICAL DRAPE
K862801 · Kimberly-Clark Corp. · Aug 1986
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969 · Deroyal Industries, Inc. · Jun 1986