Cleared Traditional

K862740 - QUINTON Q.CATH

K862740 is an FDA 510(k) clearance for QUINTON Q.CATH, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K862740 · Quinton, Inc. · Cardiovascular device
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Oct 1986
Decision
102d
Days
Class 2
Risk

K862740 is an FDA 510(k) clearance for the QUINTON Q.CATH. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on October 31, 1986 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Quinton, Inc. devices

FDA 510(k) Submission Details - K862740

510(k) Number K862740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1986
Decision Date October 31, 1986
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 374
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K862740.
EPICARDIA LE/FD
K881770 · Medicomp, Inc. · May 1988
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988
MICOR
K865010 · Siemens Medical Solutions USA, Inc. · Jul 1987
PDS 9000 PATIENT DATA MGMT. SYSTEM
K855055 · Marquette Electronics, Inc. · Feb 1986
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
SPACELABS-GENERAL SYSTEM LINK
K850627 · Spacelabs, Inc. · May 1985