# K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)

- Pathway: 510(k) (Abbreviated)
- Applicant: Mindray North America
- Decided: Apr 18, 2014 after 289 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K941811 (1994). 194 ancestors in all.
10 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)
- K092449: Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.
- K102562: Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800, Philips Medizin Systeme Boblingen GmbH (2010) Summary page 2.
- K091786: Pulsion PICCO2 (8500), Cevox Optical Module (PC3015), Cevox Disposable  Probes (PV2022-30 Thru -38, PV2022-46 Thru -48), Pulsion Medical Systems AG (2010) Summary page 2.
- K071073: Solar 8000 and Transport Pro with Patient Data Module, Ge Medical Systems Information Technologies (2007) Summary page 2.

## Most influential descendants
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (2014), 9 descendants of its own
- 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

## Indications for use
The Passport M Series patient monitors including models Passport 17M and Passport 12M are intended to be used 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, heart rate(HR)), respiration rate(RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (0.0.), continuous cardiac output (COO). mixed/central venous oxygen saturation (SvO2/ScvO2), carbon dioxide (002), Oxygen(02), anesthetic gas (AG), impedance cardiograph (lOG), bispectral index (815) and respiration mechanics (RM). All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, COO, Sv02/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.0. is only for use on adult patients. The lOG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must 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/K132075
Methodology: https://510kreport.com/methodology