Cleared Traditional

K232962 - Patient Monitor (iX10, iX12, iX15)

K232962 is an FDA 510(k) clearance for Patient Monitor (iX10, 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 211-day FDA review.

K232962 · Edan Instruments, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2024
Decision
211d
Days
Class 2
Risk

K232962 is an FDA 510(k) clearance for the Patient Monitor (iX10, iX12, iX15). 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 19, 2024 after a review of 211 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 - K232962

510(k) Number K232962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2023
Decision Date April 19, 2024
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K232962.
Infinity CentralStation Wide
K240312 · Draeger Medical Systems, Inc. · Aug 2024
Patient Monitor (RespArray)
K240320 · Edan Instruments, Inc. · Jun 2024
Corvair
K231010 · AliveCor, Inc. · Jun 2024
Central Monitoring System (MFM-CMS)
K232694 · Edan Instruments, Inc. · Feb 2024
IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
K231671 · Philips Medizin Systeme Boeblingen GmbH · Dec 2023
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
K230604 · Philips Medizin Systeme Boeblingen GmbH · Nov 2023