Cleared Traditional

K000645 - GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11

K000645 is an FDA 510(k) clearance for GE MARQUETTE MEDICAL SYSTEMS PRUCKA CAR..., manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K000645 · General Electric Medical Systems Information Techn · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2000
Decision
89d
Days
Class 2
Risk

K000645 is an FDA 510(k) clearance for the GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Sugarland, US). The FDA issued a Cleared decision on May 24, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K000645

510(k) Number K000645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2000
Decision Date May 24, 2000
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 429
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K000645.
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · Boston Medical Technologies, Inc. · Aug 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc. · Aug 2000
MODEL APS ALTERNANS PROCESSING SYSTEM
K001034 · Cambridge Heart, Inc. · Jun 2000
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2
K993414 · Prucka Engineering, Inc. · Apr 2000
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
K991786 · General Electric Medical Systems Information Techn · Nov 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · Boston Medical Technologies, Inc. · Jun 1999