Cleared Traditional

K892113 - Q5000 PC WORKSTATION

K892113 is an FDA 510(k) clearance for Q5000 PC WORKSTATION, 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 66-day FDA review.

K892113 · Quinton, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1989
Decision
66d
Days
Class 2
Risk

K892113 is an FDA 510(k) clearance for the Q5000 PC WORKSTATION. 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 May 18, 1989 after a review of 66 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K892113

510(k) Number K892113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1989
Decision Date May 18, 1989
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 K892113.
MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)
K920295 · Oxford Medilog, Inc. · Aug 1992
NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS
K905248 · Advanced Technology Laboratories, Inc. · Feb 1991
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · Hewlett-Packard Co. · Jan 1991
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
K880879 · Ppg Industries, Inc. · Jun 1988
EPICARDIA LE/FD
K881770 · Medicomp, Inc. · May 1988
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988