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)— 510(k) K260098
Substantially EquivalentShenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) clearance K260098 for 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), Substantially Equivalent on 2026-05-20. Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Device class: 2.
Summary
Shenzhen Mindray Bio-Medical Electronics' ePM Series Patient Monitor covers a list of models, from the ePM 10 through ePM 15MC, plus one named Guardian plus. The product code is MHX, physiological patient monitors with arrhythmia detection or alarms.
Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Mindray filed from Shenzhen, China. The decision came 127 calendar days after receipt (January 13 to May 20, 2026).
Clearance details
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Product code
- Product code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code MHX
view allMore clearances from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- K261617 — Diagnostic Ultrasound System (11+ models)
- K253330 — A5 Anesthesia System (A5); A7 Anesthesia System (A7)
- K260846 — Diagnostic Ultrasound System (13+ models)
- K253170 — uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K260098
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K260098.
Data sourced from openFDA. This site is unofficial and independent of the FDA.