Cleared Traditional

RAAF DUAL LUMEN CATHETER (K842176) - FDA 510(k) Clearance

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

K842176 · Quinton, Inc. · Cardiovascular device

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Jul 1984

Decision

35d

Days

Class 2

Risk

K842176 is an FDA 510(k) clearance for the RAAF DUAL LUMEN CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Quinton, Inc. (Walker, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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	K842176 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 1984
Decision Date	July 13, 1984
Days to Decision	35 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

90d faster than avg

Panel avg: 125d · This submission: 35d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DQY Catheter, Percutaneous
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1250

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 - DQY Catheter, Percutaneous

All 308

Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K842176.

MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT

K852388 · Quinton, Inc. · Aug 1985

BARD-PARKER IRRIGATION CATHETER

K852099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985

MULTIPRO CATHETER

K841797 · Shiley, Inc. · Aug 1984

MAHURKAR DUAL LIMEN FEMORAL CATHETER

K834109 · Quinton, Inc. · Feb 1984

ULTRA LIGHT RAAF CATHETER

K832784 · Quinton, Inc. · Oct 1983

AMPLATZ HEPARIN COATED CATHETER

K832178 · Cook, Inc. · Aug 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842176

Quinton, Inc.

Walker, MI · US

Regulatory profile

164 submissions 160 cleared

98% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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