Cleared Traditional

CONPHAR FEMALE CATHETER-STERILE (K791244) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K791244 · Conphar, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
63d
Days
Class 2
Risk

K791244 is an FDA 510(k) clearance for the CONPHAR FEMALE CATHETER-STERILE. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1979 after a review of 63 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 Conphar, Inc. devices

Submission Details

510(k) Number K791244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1979
Decision Date September 07, 1979
Days to Decision 63 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
67d faster than avg
Panel avg: 130d · This submission: 63d
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 52
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K791244.
CONPHAR SILICONE COATED FOLEY CATH
K792111 · Conphar, Inc. · Nov 1979
DYNACOR STERILE CARELON SILICONE CATH.
K791992 · Medline Industries, Inc. · Oct 1979
BARD URODYNAMIC CATHETERS
K791717 · C.R. Bard, Inc. · Sep 1979
CONPHAR NELATON CATHETER-STERILE
K791264 · Conphar, Inc. · Aug 1979
UNIVERSAL FOLEY CATHETER TRAY
K791332 · Abco Dealers, Inc. · Aug 1979
STERILE 100% SILICONE FOLEY CATHETER
K780675 · Medline Industries, Inc. · May 1978