Cleared Traditional

K843126 - MEDIFLEX DRAINAGE BAG

K843126 is the FDA 510(k) clearance for MEDIFLEX DRAINAGE BAG by Mediflex Intl.. It is a Class 2 Gastroenterology & Urology device (product code KNX) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K843126 · Mediflex Intl. · Gastroenterology & Urology device
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Oct 1984
Decision
55d
Days
Class 2
Risk

K843126 is an FDA 510(k) clearance for the MEDIFLEX DRAINAGE BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Mediflex Intl. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 55 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.

View all Mediflex Intl. devices

Submission Details

510(k) Number K843126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1984
Decision Date October 04, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 71
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K843126.
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
K844684 · Coloplast A/S · Jan 1985
FEMALE URINARY INCONTINENCE SYS
K843128 · Chesebrough-Pond'S U.S.A. Co. · Jan 1985
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · Travenol Laboratories, S.A. · Dec 1984
SUR-FIT NIGHT DRAINAGE CONTAINER SET
K842395 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
ACCUSEAL LEG BAGS & EXTENSION TUBES
K842396 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
URIHESIVE SYS MALE EXTERNAL CATHETER
K842397 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984