Cleared Traditional

MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY (K885188) - FDA 510(k) Clearance

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

K885188 · Quinton, Inc. · Cardiovascular device
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Feb 1989
Decision
61d
Days
Class 2
Risk

K885188 is an FDA 510(k) clearance for the MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on February 6, 1989 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight 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 K885188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1988
Decision Date February 06, 1989
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 104
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K885188.
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K900753 · Shiley, Inc. · Apr 1990
MODIFIED STOCKERT-SHILEY VENOUS CATHETER
K890980 · Shiley, Inc. · May 1989
SARNS VENT CATHETER
K890024 · 3M Company · Mar 1989
MODIFIED SHILEY FEMORAL ARTERIAL CANNULA
K884393 · Shiley, Inc. · Dec 1988
EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
K882771 · Cook, Inc. · Sep 1988
SHILEY FEMORAL CORONARY PERFUSION CATHETER
K881733 · Shiley, Inc. · Jul 1988