Cleared Traditional

CATHETER WITH HARD VALVE (K770489) - FDA 510(k) Clearance

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

K770489 · Pharmaseal Div., Baxter Healthcare Corp. · Gastroenterology & Urology device
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Mar 1977
Decision
7d
Days
Class 2
Risk

K770489 is an FDA 510(k) clearance for the CATHETER WITH HARD VALVE. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1977 after a review of 7 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 Pharmaseal Div., Baxter Healthcare Corp. devices

Submission Details

510(k) Number K770489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1977
Decision Date March 21, 1977
Days to Decision 7 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
123d faster than avg
Panel avg: 130d · This submission: 7d
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 38
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K770489.
STERILE 100% SILICONE FOLEY CATHETER
K780675 · Medline Industries, Inc. · May 1978
STERILE CLOSED SYSTEM
K780676 · Medline Industries, Inc. · May 1978
CATHETER, URETHERAL
K770814 · C.R. Bard, Inc. · Oct 1977
TRAVACATH
K770493 · Travenol Laboratories, S.A. · Mar 1977
RUTNER UNIVERSAL WEDGE CATHETER
K760858 · Cook, Inc. · Dec 1976
CATHETER 3-WAY SILICONE FOLEY
K760259 · Travenol Laboratories, S.A. · Aug 1976