Cleared Traditional

K202336 - Patient Monitor

K202336 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 159-day FDA review.

K202336 · Edan Instruments, Inc. · Cardiovascular device
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Jan 2021
Decision
159d
Days
Class 2
Risk

K202336 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 January 23, 2021 after a review of 159 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 - K202336

510(k) Number K202336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date January 23, 2021
Days to Decision 159 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
34d slower than avg
Panel avg: 125d · This submission: 159d
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 Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 322
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K202336.
Infinity Acute Care System (IACS) Monitoring Solution
K201764 · Draeger Medical Systems, Inc. · Dec 2021
IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
K210906 · Philips Medizin Systeme Boeblingen GmbH · Oct 2021
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
K203435 · Nihon Kohden Corporation · Jul 2021
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
K202405 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2021
Monitor B125, Monitor B105
K201941 · Ge Medical Systems Information Technologies, Inc. · Nov 2020
Tempus Pro Patient Monitor
K201746 · Remote Diagnostic Technologies Limited · Sep 2020