Cleared Traditional

K933148 - SURGICAL DRAPE KIT

K933148 is an FDA 510(k) clearance for SURGICAL DRAPE KIT, manufactured by Nobelpharma USA, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 727-day FDA review.

K933148 · Nobelpharma USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
727d
Days
Class 2
Risk

K933148 is an FDA 510(k) clearance for the SURGICAL DRAPE KIT. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on June 26, 1995 after a review of 727 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 Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K933148

510(k) Number K933148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date June 26, 1995
Days to Decision 727 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
598d slower than avg
Panel avg: 129d · This submission: 727d
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 272
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K933148.
VOLMED OPERATION DRAPE
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DEROYAL SURGICAL INSTRUMENT DRAPE
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K945755 · Thantex Specialties, Inc. · May 1995
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
K946060 · Remington Medical, Inc. · Apr 1995
OREX SURGICAL DRAPES
K944859 · Thantex Specialties, Inc. · Feb 1995