Cleared Traditional

K841735 - ACU-DERM TRANSPARENT INCISE DRAPE

K841735 is an FDA 510(k) clearance for ACU-DERM TRANSPARENT INCISE DRAPE, manufactured by Acme United Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K841735 · Acme United Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
98d
Days
Class 2
Risk

K841735 is an FDA 510(k) clearance for the ACU-DERM TRANSPARENT INCISE DRAPE. 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 2, 1984 after a review of 98 days - within the typical 510(k) review window.

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: 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 Acme United Corp. devices

FDA 510(k) Submission Details - K841735

510(k) Number K841735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1984
Decision Date August 02, 1984
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

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 274
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K841735.
PMS DRAPE PACK
K844465 · Professional Medical Services · Dec 1984
ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET
K844199 · Kleen Test Products · Nov 1984
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · Busse Hospital Disposables, Inc. · Oct 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984
ANTIMICROBIAL INCISE DRAPE
K840957 · American Convertors Div., American Pharmaseal · Jun 1984
SINGLE-USE SURGICAL DRAPES
K833877 · Procter & Gamble Mfg. Co. · Jan 1984