Cleared Traditional

K242562 - Monitor B105M

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

K242562 is the FDA 510(k) clearance for Monitor B105M by Ge Medical Systems Information Technologies, Inc.. It is a Class 2 Cardiovascular device (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
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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

Submission Details

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.

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

All 274
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