Cleared Traditional

ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX (K000442) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000442 · Medical Concepts Development, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
439d
Days
Class 2
Risk

K000442 is an FDA 510(k) clearance for the ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Medical Concepts Development, Inc. (Woodbury, US). The FDA issued a Cleared decision on April 24, 2001 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medical Concepts Development, Inc. devices

Submission Details

510(k) Number K000442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2000
Decision Date April 24, 2001
Days to Decision 439 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
310d slower than avg
Panel avg: 129d · This submission: 439d
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 23
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K000442.
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · Medline Industries, Inc. · Feb 1997
STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE
K962205 · Medline Industries, Inc. · Nov 1996