Ge Medical Systems Information Technologies, Inc. · Class II · Cleared Jul 9, 2025
| K-number | K242562 |
| Device name | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product code | MHX |
| Device class | Class II |
| Decision date | Jul 9, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1025 |
The Monitor B105M, B125M, B155M, B105P, and B125P are portable multi-parameter patient monitors for hospital use and intra-hospital transport. They monitor and display ECG (including ST-segment and arrhythmia detection), blood pressure (invasive and non-invasive), heart rate, oxygen saturation, temperature, respiration, airway gases, cardiac output, entropy, neuromuscular transmission, and Bispectral Index (BIS). The devices are intended for use under direct supervision of a licensed healthcare practitioner and are not for apnea detection or life-sustaining purposes.
The proposed monitors retain equivalent hardware design and the same LCD display sizes as the predicate (K213490) but incorporate new software (VSP 4.0 versus VSP 3.0), add support for the Bispectral Index (BIS) parameter via an existing cleared E-BIS module, remove the Trim-knob for improved cleanability, add gesture-based audio pause control, separate low-priority alarm volume settings, support connection to GE anesthesia devices, and include cybersecurity enhancements such as encrypted HL7 and NTP protocols.
IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-1-2:2020, IEC 60601-1-8:2020, IEC 60601-2-26:2019/COR1:2021, IEC 60601-2-27:2011+C1:2012, IEC 80601-2-30:2018, IEC 60601-2-34:2011, IEC 60601-2-40:2016, IEC 80601-2-49:2018, ISO 80601-2-56:2017+A1:2018, ISO 80601-2-61:2017+C1:2018, IEC 62304:2006+A1:2015, ISO 14971:2019, IEC 62366-1:2020, and IEEE ANSI C63.27-2021 for wireless performance.
The proposed devices are substantially equivalent because they maintain the same indications for use, intended patient populations (adult, pediatric, neonatal), use environment, and primary function as the predicate. The hardware functionality is unchanged with identical physical dimensions and display sizes. All changes—including BIS parameter support through existing cleared modules, software enhancements, removal of the Trim-knob, alarm configuration improvements, and cybersecurity upgrades—are incremental enhancements that do not alter the fundamental technology or clinical purpose. The devices continue to provide all required operations through the same touch-screen interface and meet the same consensus standards.
View the full FDA submission: accessdata.fda.gov