Cleared Traditional

K021864 - PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)

K021864 is an FDA 510(k) clearance for PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPH..., manufactured by Primeline Medical Products, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K021864 · Primeline Medical Products, Inc. · General Hospital
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Sep 2002
Decision
109d
Days
Class 2
Risk

K021864 is an FDA 510(k) clearance for the PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, P.... Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Primeline Medical Products, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on September 23, 2002 after a review of 109 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 Primeline Medical Products, Inc. devices

FDA 510(k) Submission Details - K021864

510(k) Number K021864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2002
Decision Date September 23, 2002
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
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 226
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K021864.
TRILAMINATE DRAPES/TIBURON
K023419 · Allegiance Healthcare Corp. · Feb 2003
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · Allegiance Healthcare Corp. · Nov 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
WOUND PROTECTOR/RETRACTOR
K020435 · Applied Medical Resources Corp. · Apr 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957 · Dynarex Corp. · Mar 2002
MODIFICATION TO: COMPEL SURGICAL DRAPES
K012807 · Standard Textile Co., Inc. · Oct 2001