Cleared Traditional

K101127 - PATIENT MONITOR

K101127 is the FDA 510(k) clearance for PATIENT MONITOR by Contec Medical System Co., Ltd.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K101127 · Contec Medical System Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
50d
Days
Class 2
Risk

K101127 is an FDA 510(k) clearance for the PATIENT MONITOR, MODEL PM50. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Contec Medical System Co., Ltd. (Zhong Shan, Shanghai, CN). The FDA issued a Cleared decision on June 11, 2010 after a review of 50 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.

View all Contec Medical System Co., Ltd. devices

Submission Details

510(k) Number K101127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2010
Decision Date June 11, 2010
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
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 124
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K101127.
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K110516 · Welch Allyn, Inc. · Jun 2011
CARESCAPE MODEL V100 VITAL SIGNS MONITOR
K102426 · Ge Medical Systems Information Technologies · Oct 2010
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
K101259 · Taidoc Technology Corporation · Jun 2010
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · Welch Allyn, Inc. · Jun 2010
INTELLIBRIDGE SYSTEM
K093177 · Philips Medical Systems · Dec 2009
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · Omron Healthcare, Inc. · Oct 2008