# K190011: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 10, 2019 after 188 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 38 generations back to K941811 (1994). 383 ancestors in all.
No later device cites it as a predicate yet.
11 of 384 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152902: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2016) Summary page 7.
- K170876: Passport Series Patient Monitors (Passport 12m, Passport 17m), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2017) Summary page 7.
- K182075: BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2018) Summary page 7.
- K171292: A7 Anesthesia System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2018) Summary page 7.

## Recalls of this device
- Aug 31, 2026 · Class III · Z-0116-2027: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Aug 31, 2026 · Class III · Z-0114-2027: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions

## 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, 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.), 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), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). 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, PAWP monitoring and NMT 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, QT 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/K190011
Methodology: https://510kreport.com/methodology