Cleared Traditional

K925067 - SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

K925067 is an FDA 510(k) clearance for SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG, manufactured by Simport Plastics, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K925067 · Simport Plastics, Ltd. · Gastroenterology & Urology device
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Jun 1993
Decision
248d
Days
Class 2
Risk

K925067 is an FDA 510(k) clearance for the SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Simport Plastics, Ltd. (United Kingdom, GB). The FDA issued a Cleared decision on June 10, 1993 after a review of 248 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Simport Plastics, Ltd. devices

FDA 510(k) Submission Details - K925067

510(k) Number K925067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1992
Decision Date June 10, 1993
Days to Decision 248 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 130d · This submission: 248d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 81
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K925067.
NEEDLELESS URINE SAMPLING PORT
K944236 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · C.R. Bard, Inc. · Sep 1994
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570 · Hollister, Inc. · May 1993
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223 · Medical Device Inspection Co., Inc. · Sep 1991
URINE COLLECTOR LEG BAG
K896688 · Medline Industries, Inc. · May 1990