Cleared Traditional

K843478 - PHARMA-PLAST URIDROP-URIDOME

K843478 is an FDA 510(k) clearance for PHARMA-PLAST URIDROP-URIDOME, manufactured by Zimmar Consulting , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K843478 · Zimmar Consulting , Ltd. · Gastroenterology & Urology device
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Dec 1984
Decision
90d
Days
Class 2
Risk

K843478 is an FDA 510(k) clearance for the PHARMA-PLAST URIDROP-URIDOME. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Zimmar Consulting , Ltd. (Walker, US). The FDA issued a Cleared decision on December 5, 1984 after a review of 90 days - within the typical 510(k) review window.

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 Zimmar Consulting , Ltd. devices

FDA 510(k) Submission Details - K843478

510(k) Number K843478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date December 05, 1984
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 100
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K843478.
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
PHARMA-PLAST CONNECTING TUBE TYPE URIN-
K843481 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST LEG BAG
K843479 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST URINARY DRAINAGE BAG 2000
K843480 · Zimmar Consulting , Ltd. · Oct 1984