Cleared Traditional

DINAMAP PROCARE SERIES MONITOR (K014255) - FDA 510(k) Clearance

Also marketed or referenced as:
MODEL 100, 200, 300, 400

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

K014255 · Ge Medical Systems Information Technologies · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
188d
Days
Class 2
Risk

K014255 is an FDA 510(k) clearance for the DINAMAP PROCARE SERIES MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Tampa, US). The FDA issued a Cleared decision on July 2, 2002 after a review of 188 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

Submission Details

510(k) Number K014255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2001
Decision Date July 02, 2002
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 111
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K014255.
MODIFICATION TO UNITY NETWORK ID
K033672 · Ge Medical Systems Information Technologies · Dec 2003
BEDSIDE MONITOR, MODEL OPV-1500
K032749 · Nihon Kohden America, Inc. · Sep 2003
M2376A DEVICELINK SYSTEM
K030731 · Philips Medical Systems, Inc. · Mar 2003
M2376 DEVICELINK SYSTEM
K021912 · Philips Medical Systems, Inc. · Jun 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
K021435 · Ge Medical Systems Information Technologies · May 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K020494 · Philips Medical Systems, Inc. · Feb 2002