# K260098: 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)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 20, 2026 after 127 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K182075 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200015: ePM Series Patient monitors, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2020) Summary page 7.

## Recalls of this device
- Aug 31, 2026 · Class III · Z-0109-2027: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

## Indications for use
The ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 1OM/ ePM 1OMA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC patient monitors are intended for monitoring, displaying, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non- invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2), Oxygen (02) and Anesthetic Gas (AG), Bispectral Index (BIS), Neuromuscular Transmission Monitoring (NMT). The system also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following: • NMT, the PAWP monitoring is intended for adult and pediatric patients only; • BIS monitoring is only intended for patients aged 4 years and above; • C.O. monitoring is intended for adult and pediatric patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The ePM 10/10A/1 0C/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 monitors are not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K260098
Methodology: https://510kreport.com/methodology