Cleared Traditional

K890072 - PRIMROSE FEMALE EXT. CATH OR EXT. URINA...

K890072 is an FDA 510(k) clearance for PRIMROSE FEMALE EXT. CATH OR EXT. URINA..., manufactured by Medireach, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K890072 · Medireach, Inc. · Gastroenterology & Urology device
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Jun 1989
Decision
154d
Days
Class 2
Risk

K890072 is an FDA 510(k) clearance for the PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Medireach, Inc. (Dallas, US). The FDA issued a Cleared decision on June 12, 1989 after a review of 154 days - an extended review 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: 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 Medireach, Inc. devices

FDA 510(k) Submission Details - K890072

510(k) Number K890072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1989
Decision Date June 12, 1989
Days to Decision 154 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
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K890072.
MENTOR INFUSION LINE
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FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TECNOL CATHETER LEG STRAP
K882641 · Tecnol New Jersey Wound Care, Inc. · Jul 1988
DEFLECTING GUIDE WIRE
K833242 · Van-Tec, Inc. · Oct 1983
SAFEED DISP. PLASTIC CATHETER
K771212 · Terumo America, Inc. · Sep 1977