Cleared Traditional

K242562 - Monitor B105M

Also marketed or referenced as:
Monitor B125M Monitor B155M Monitor B105P Monitor B125P

K242562 is an FDA 510(k) clearance for Monitor B105M, manufactured by Ge Medical Systems Information Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K242562 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
315d
Days
Class 2
Risk

K242562 is an FDA 510(k) clearance for the Monitor B105M. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on July 9, 2025 after a review of 315 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.

View all Ge Medical Systems Information Technologies, Inc. devices

FDA 510(k) Submission Details - K242562

510(k) Number K242562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2024
Decision Date July 09, 2025
Days to Decision 315 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
190d slower than avg
Panel avg: 125d · This submission: 315d
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 K242562.
IntelliVue Patient monitors MX400, MX450, MX500, MX550
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Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
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K250757 · Masimo Corporation · May 2025
Telemetry Monitor 5500 Release 4.0 (867232)
K242962 · Philips Medizin Systeme B?blingen GmbH · May 2025
Infinity CentralStation Wide
K240312 · Draeger Medical Systems, Inc. · Aug 2024