Cleared Traditional

K994199 - VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR

K994199 is an FDA 510(k) clearance for VARIOUS STERILE AND NON-STERILE SURGICA..., manufactured by Custom 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 179-day FDA review.

K994199 · Custom Medical Products, Inc. · General Hospital
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Jun 2000
Decision
179d
Days
Class 2
Risk

K994199 is an FDA 510(k) clearance for the VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PRO.... Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Custom Medical Products, Inc. (Asheville, US). The FDA issued a Cleared decision on June 9, 2000 after a review of 179 days - an extended review 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: 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 Custom Medical Products, Inc. devices

FDA 510(k) Submission Details - K994199

510(k) Number K994199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date June 09, 2000
Days to Decision 179 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 129d · This submission: 179d
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 262
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K994199.
NEUROTOLOGY DRAPE, MODEL TBD
K002702 · Gyrus Ent LLC · Oct 2000
EQUIPMENT DRAPES
K002508 · Allegiance Healthcare Corp. · Sep 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp. · Jun 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · Allegiance Healthcare Corp. · Mar 2000
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
CONVERTORS SURGICAL DRAPES
K993795 · Allegiance Healthcare Corp. · Jan 2000