Cleared Traditional

K842890 - PERCUFIX CATHETER CUFF

K842890 is the FDA 510(k) clearance for PERCUFIX CATHETER CUFF by Medi-Tech, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K842890 · Medi-Tech, Inc. · Gastroenterology & Urology device
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Sep 1984
Decision
43d
Days
Class 2
Risk

K842890 is an FDA 510(k) clearance for the PERCUFIX CATHETER CUFF. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Watertown, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K842890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date September 04, 1984
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 73
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K842890.
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · American Edwards Laboratories · Mar 1985
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · Abco Dealers, Inc. · Jul 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984
TEMPERATURE SENSING FOLEY CATHETER
K834438 · C.R. Bard, Inc. · Feb 1984