Cleared Traditional

Q3000 (K834567) - FDA 510(k) Clearance

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

K834567 · Quinton, Inc. · Cardiovascular device
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Apr 1984
Decision
124d
Days
Class 2
Risk

K834567 is an FDA 510(k) clearance for the Q3000. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Quinton, Inc.. The FDA issued a Cleared decision on April 30, 1984 after a review of 124 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

Submission Details

510(k) Number K834567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1983
Decision Date April 30, 1984
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 174
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K834567.
MICOR
K865010 · Siemens Medical Solutions USA, Inc. · Jul 1987
QUINTON Q.CATH
K862740 · Quinton, Inc. · Oct 1986
SIRECUST 425, RESPECTIVELY SIRECUST 430
K851637 · Siemens Medical Solutions USA, Inc. · Jul 1985
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979
MODEL 5621A INTERFACE
K780768 · Hewlett-Packard Co. · May 1978