Cleared Traditional

K160981 - Patient Monitor

K160981 is an FDA 510(k) clearance for Patient Monitor, manufactured by Edan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K160981 · Edan Instruments, Inc. · Cardiovascular device
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Dec 2016
Decision
259d
Days
Class 2
Risk

K160981 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 Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 22, 2016 after a review of 259 days - an extended review cycle.

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. 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 Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K160981

510(k) Number K160981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2016
Decision Date December 22, 2016
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 Consultant

Edan Medical
DOUG WORTH

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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 331
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K160981.
Nihon Kohden Vital Sign Telemeter
K163459 · Nihon Kohden Corporation · Apr 2017
Telemetry Transmitter
K161056 · Edan Instruments, Inc. · Feb 2017
Mortara Surveyor Patient Monitor
K161517 · Mortara Instrument, Inc. · Jan 2017
Nihon Kohden Vital Sign Telemeter
K153707 · Nihon Kohden Corporation · Sep 2016
Surveyor S4 Mobile Monitor
K160685 · Mortara Instrument, Inc. · Aug 2016
IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2
K161531 · Philips Medizin Systeme Boeblingen GmbH · Jul 2016