Cleared Traditional

K855055 - PDS 9000 PATIENT DATA MGMT. SYSTEM

K855055 is the FDA 510(k) clearance for PDS 9000 PATIENT DATA MGMT. SYSTEM by Marquette Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K855055 · Marquette Electronics, Inc. · Cardiovascular device
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Feb 1986
Decision
56d
Days
Class 2
Risk

K855055 is an FDA 510(k) clearance for the PDS 9000 PATIENT DATA MGMT. SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 56 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 Marquette Electronics, Inc. devices

Submission Details

510(k) Number K855055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1985
Decision Date February 12, 1986
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 260
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K855055.
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM
K874171 · Hewlett-Packard Co. · Feb 1988
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
SPACELABS-GENERAL SYSTEM LINK
K850627 · Spacelabs, Inc. · May 1985
Q3000
K834567 · Quinton, Inc. · Apr 1984