# K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 3, 2016 after 94 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: 33 generations back to K941811 (1994). 267 ancestors in all.
No later device cites it as a predicate yet.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132662: Passport Series Patient Monitors, Shenzhen Mindray Biomedical Electronics Co., Ltd. (2014) Summary page 5.
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M), Mindray North America (2014) Summary page 5.
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O, Philips Medical Systems (2010) Summary page 5.
- K150352: V Series Monitoring System (including V12 and V21 Monitors), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 5.
- K150632: Hypervisor IX Monitoring System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2015) Summary page 5.

## Recalls of this device
- Aug 31, 2026 · Class III · Z-0115-2027: 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
The Passport Series Patient Monitors(Passport 8 and Passport 12), are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, QT analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: • C.O. monitoring is restricted to adult patients only; • PAWP monitoring is not intended for neonatal patients; • The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only. • 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitor only. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Source page: https://510kreport.com/device/K153448
Methodology: https://510kreport.com/methodology