Cleared Traditional

Patient Monitor (K152552) - FDA 510(k) Clearance

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

K152552 · Edan Instruments, Inc. · Cardiovascular device
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Apr 2016
Decision
234d
Days
Class 2
Risk

K152552 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 April 29, 2016 after a review of 234 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

Submission Details

510(k) Number K152552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date April 29, 2016
Days to Decision 234 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
109d slower than avg
Panel avg: 125d · This submission: 234d
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 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 196
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K152552.
Patient Monitor
K160981 · Edan Instruments, Inc. · Dec 2016
M3290B Philips IntelliVue Information Center iX
K153702 · Philips Medical Systems · Jun 2016
Philips Efficia CMS200 Central Monitoring System
K160951 · Philips Medical Systems · May 2016
AVIVO Mobile Patient Management (MPM) System
K153160 · Medtronic, Inc. · Mar 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2016