Cleared Traditional

K946024 - 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7...

K946024 is an FDA 510(k) clearance for 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7..., manufactured by 3M Healthcare. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K946024 · 3M Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
61d
Days
Class 2
Risk

K946024 is an FDA 510(k) clearance for the 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by 3M Healthcare (St. Paul, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 61 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Healthcare devices

FDA 510(k) Submission Details - K946024

510(k) Number K946024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1994
Decision Date February 08, 1995
Days to Decision 61 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
68d faster than avg
Panel avg: 129d · This submission: 61d
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 184
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K946024.
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · Deroyal Industries, Inc. · Dec 1995
SURGICAL DRAPE KIT
K933148 · Nobelpharma USA, Inc. · Jun 1995
COMPEL SURGICALDRAPES
K944863 · Standard Textile Co., Inc. · Feb 1995
CIVCO PROBE BOOT/CORD COVER
K943393 · CIVCO Medical Instruments Co., Inc. · Feb 1995
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994
SURGICAL DRAPES
K943122 · Mallinckrodt Group, Inc. · Sep 1994