Cleared Traditional

K022537 - PRESS-MATE PM-2100 VITAL SIGN MONITOR

K022537 is an FDA 510(k) clearance for PRESS-MATE PM-2100 VITAL SIGN MONITOR, manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K022537 · Colin Medical Instruments Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
43d
Days
Class 2
Risk

K022537 is an FDA 510(k) clearance for the PRESS-MATE PM-2100 VITAL SIGN MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (San Antonio, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022537

510(k) Number K022537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2002
Decision Date September 13, 2002
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 308
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K022537.
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
DINAMAP PROCARE SERIES MONITOR
K014255 · Ge Medical Systems Information Technologies · Jul 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
K022537 · PRESS-MATE PM-2100 VITAL SIGN MONITOR
Download PDF FDA Summary Colin Medical Instrum…