Cleared Traditional

K014255 - DINAMAP PROCARE SERIES MONITOR

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

K014255 is an FDA 510(k) clearance for DINAMAP PROCARE SERIES MONITOR, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 188-day FDA review.

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

FDA 510(k) Submission Details - K014255

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.

MWI Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K014255.
M2376A DEVICELINK SYSTEM
K030731 · Philips Medical Systems, Inc. · Mar 2003
UNITY NETWORK ID
K021454 · General Electric Medical Systems Information Techn · Oct 2002
M2376A DEVICELINK SYSTEM
K022920 · Philips Medical Systems · Sep 2002
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
K021347 · Philips Medical Systems · May 2002