Cleared Traditional

K012915 - DINAMAP PRO 1000 MONITOR

K012915 is an FDA 510(k) clearance for DINAMAP PRO 1000 MONITOR, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K012915 · Ge Medical Systems Information Technologies · Cardiovascular device
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Mar 2002
Decision
203d
Days
Class 2
Risk

K012915 is an FDA 510(k) clearance for the DINAMAP PRO 1000 MONITOR, MODEL 1000. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Tampa, US). The FDA issued a Cleared decision on March 21, 2002 after a review of 203 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Ge Medical Systems Information Technologies devices

FDA 510(k) Submission Details - K012915

510(k) Number K012915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date March 21, 2002
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K012915.
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K020531 · Philips Medical Systems · Mar 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
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K011540 · Datascope Corp. · Feb 2002