Cleared Traditional

K101692 - PATIENT MONITOR (FDA 510(k) Clearance)

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

K101692 · Contec Medical System Co., Ltd. · Cardiovascular device
Jun 2011
Decision
377d
Days
Class 2
Risk

K101692 is an FDA 510(k) clearance for the PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Contec Medical System Co., Ltd. (Zhong Shan, Shanghai, CN). The FDA issued a Cleared decision on June 28, 2011 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K101692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2010
Decision Date June 28, 2011
Days to Decision 377 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 140d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 34
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K101692.
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IntelliVue Patient monitors MX400, MX450, MX500, MX550
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IntelliVue Patient Monitor 6100 (6100)
K250453 · Philips Medizin Systeme B?blingen GmbH · Sep 2025