# K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.
- Decided: Dec 22, 2014 after 46 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: 31 generations back to K941811 (1994). 195 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M), Mindray North America (2014) Summary page 7.

## Most influential descendants
- K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (2016), 6 descendants of its own
- K170876: Passport Series Patient Monitors (Passport 12m, Passport 17m) (2017), 3 descendants of its own
- K191106: C50 and C80 Multi-parameter Patient Monitor (2019), 1 descendant of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K211619: Multi-Parameter Patient Monitor (2022), 0 descendants of its own

## Recalls of this device
- Jun 23, 2016 · Class II · Z-2549-2016: Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

## Indications for use
Passport 12M and 17M Patient Monitors: The Passport 17M and Passport 12M patient monitors are intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment 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.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS), and respiration mechanics (RM). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/ScvO2, and PAWP monitoring are intended for adult and pediatric patients only; • ST Segment analysis of Mindray algorithm is intended for adult patients only; • C.O. monitoring is restricted to adult patients only; • ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use. T1 Patient Monitor: The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing , alarming, and transferring of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). The equipment also provides an interpretation of resting 12-lead ECG. All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: The arrhythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients; ST Segment analysis of Mindray ECG algorithm is intended for adult patients only; The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K143195
Methodology: https://510kreport.com/methodology