Cleared Traditional

K931418 - SURGICAL DRAPE

K931418 is an FDA 510(k) clearance for SURGICAL DRAPE, manufactured by Custom Medical Products, Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 409-day FDA review.

K931418 · Custom Medical Products, Ltd. · General Hospital
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May 1994
Decision
409d
Days
Class 2
Risk

K931418 is an FDA 510(k) clearance for the SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Custom Medical Products, Ltd. (Asheville, US). The FDA issued a Cleared decision on May 5, 1994 after a review of 409 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 Custom Medical Products, Ltd. devices

FDA 510(k) Submission Details - K931418

510(k) Number K931418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date May 05, 1994
Days to Decision 409 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
280d slower than avg
Panel avg: 129d · This submission: 409d
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 167
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K931418.
SURGICAL DRAPES
K943122 · Mallinckrodt Group, Inc. · Sep 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 1994
MEDSURG STERILE O.R. TOWELS
K940175 · Medsurg Industries, Inc. · May 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · Baxter Healthcare Corp · Apr 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994