Cleared Traditional

K843481 - PHARMA-PLAST CONNECTING TUBE TYPE URIN-

K843481 is an FDA 510(k) clearance for PHARMA-PLAST CONNECTING TUBE TYPE URIN-, 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 42-day FDA review.

K843481 · Zimmar Consulting , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
42d
Days
Class 2
Risk

K843481 is an FDA 510(k) clearance for the PHARMA-PLAST CONNECTING TUBE TYPE URIN-. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Zimmar Consulting , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 42 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 Zimmar Consulting , Ltd. devices

FDA 510(k) Submission Details - K843481

510(k) Number K843481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date October 18, 1984
Days to Decision 42 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
89d faster than avg
Panel avg: 131d · This submission: 42d
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 K843481.
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 URIDROP-URIDOME
K843478 · Zimmar Consulting , Ltd. · Dec 1984
PHARMA-PLAST LEG BAG
K843479 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST URINARY DRAINAGE BAG 2000
K843480 · Zimmar Consulting , Ltd. · Oct 1984
CORPAK URINARY DRAINAGE BAG
K842257 · Corpak Co. · Aug 1984