# K091834: Passport V Monitor, Model 0998-00-6100

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp., Patient Monitoring Division
- Decided: Jul 15, 2009 after 23 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: 13 generations back to K941811 (1994). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031849: Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx, Datascope Corp. (2003) Summary page 1.
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K091068: Accutorr V Monitor, Model 0998-00-2000, Datascope Corp., Patient Monitoring Division (2009) Summary page 1.

## Recalls of this device
- Jan 23, 2015 · Class II · Z-1280-2015: An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) which may provide an incorrect IBP measurement
- Apr 28, 2010 · Not classified · Z-1785-2010: An issue with the Passport V Monitor has been identified where the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure functions are not operational.

## Indications for use
The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters: ECG waveform derived from 3 or 5 lead measurements Heart Rate derived from selected sources (ECG, SpO2, IBP) Pulse Oximetry (SpO2 ) ST Segment Analysis derived from 3 or 5 lead measurements Arrhythmia Detection derived from 3 or 5 lead measurements Non Invasive. Blood Pressure (NIBP) Invasive Blood Pressure (IBP) - up to two (2) channels Carbon Dioxide (CO 2) Respiration Rate derived from ECG or C02 Temperature IVDrug Calculations The target populations are adult, pediatric and neonate with the exception of the: * Arrhythmia detection and ST Segment Analysis for which the target populations are adult and pediatric only, and N IVDrug Calculations for which the target population is adult only The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

Source page: https://510kreport.com/device/K091834
Methodology: https://510kreport.com/methodology