ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
FDA 510(k) K260098 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) numberK260098
Submission
- Device name
- ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen, CN - Received
- January 13, 2026
- Decision date
- May 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
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| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model…MHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/10/2026SE |
More from Shanghai Draeger Medical Instrument Co., Ltd.
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| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ · Traditional | 06/25/2026SE |
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| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | 04/16/2026SE |
| K252182 | SV70 Ventilator (SV70)MNT · Traditional | 04/06/2026SE |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona…IYN · Traditional | 02/11/2026SE |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus…IYN · Traditional | 12/03/2025SE |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…IYN · Traditional | 11/07/2025SE |
| K251820 | ViewMateTM Ultrasound SystemIYN · Traditional | 09/12/2025SE |
| K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System…IYN · Traditional | 09/05/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | 08/28/2025SE |
Questions and answers
When was ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) cleared by the FDA?
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) (K260098) received a 510(k) decision of Substantially Equivalent on May 20, 2026, 127 days after the submission was received.
What is the product code of K260098?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.