Cleared Traditional

QUINTON SINGLE LUMEN CATHETER (K893188) - FDA 510(k) Clearance

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

K893188 · Quinton, Inc. · Gastroenterology & Urology device
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Jun 1989
Decision
34d
Days
Class 2
Risk

K893188 is an FDA 510(k) clearance for the QUINTON SINGLE LUMEN CATHETER. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on June 8, 1989 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Quinton, Inc. devices

Submission Details

510(k) Number K893188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1989
Decision Date June 08, 1989
Days to Decision 34 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
96d faster than avg
Panel avg: 130d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPB Catheter, Hemodialysis, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MPB Catheter, Hemodialysis, Non-implanted

All 15
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K893188.
NIAGARA SLIM-CATH
K010778 · C.R. Bard, Inc. · Apr 2001
MAHURKAR 8 FR DUAL LEMEN CATHETER
K955002 · Quinton, Inc. · Sep 1996
MODIFIED QUINTON SINGLE LUMEN CATHETER
K896252 · Quinton, Inc. · Jan 1990
MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH
K880583 · Quinton, Inc. · Feb 1988
10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE
K871360 · Quinton, Inc. · Apr 1987