Cleared Traditional

K874309 - URETHAL CATHETER

K874309 is an FDA 510(k) clearance for URETHAL CATHETER, manufactured by Medovations, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K874309 · Medovations, Inc. · Gastroenterology & Urology device
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Dec 1987
Decision
48d
Days
Class 2
Risk

K874309 is an FDA 510(k) clearance for the URETHAL CATHETER. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 7, 1987 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K874309

510(k) Number K874309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date December 07, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 131d · This submission: 48d
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 205
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K874309.
GENT-L-KARE STERILE URINARY LEG BAG
K881217 · Geneva Laboratories, Inc. · Jul 1988
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
K881213 · Geneva Laboratories, Inc. · Jul 1988
CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
K880034 · Lin-Mark, Inc. · Mar 1988
P. URINE METER, 250CC
K872824 · Ni-Med, Inc. · Oct 1987
MMG CATH-N-PLACE
K873136 · Medical Technologies of Georgia · Sep 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · Coloplast A/S · Jun 1987
K874309 · URETHAL CATHETER
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