# K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Jan 13, 2000 after 87 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 3 generations back to K933143 (1994). 23 ancestors in all.
119 later devices descend from it; 4 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972282: Spacelabs Medical Pcis Patient Monitors, Spacelabs Medical, Inc. (1997) Summary page 2.
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496, Spacelabs Medical, Inc. (1998) Summary page 2.
- K961139: Eagle Patient Monitor Model 3000/3100, Marquette Electronics, Inc. (1996) Summary page 2.
- K960272: Eagle 3000/3100 Patient Monitor, Marquette Electronics, Inc. (1996) Summary page 2.
- K960418: Eagle Patient Monitor, Marquette Electronics, Inc. (1996) Summary page 2.
- K974178: Passport 5L-CE Model 0998-00-0131XXX, Datascope Corp. (1998) Summary page 2.
- K983575: Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX, Datascope Corp. (1999) Summary page 2.

## Most influential descendants
- K032733: PM-8000 Patient Monitor, Model 8000 (2004), 88 descendants of its own
- K043348: Modification to PM-8000 Patient Monitor (2005), 87 descendants of its own
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX (2002), 75 descendants of its own
- K053234: PM-9000 Express Patient Monitor (2006), 71 descendants of its own
- K053193: PM-8000 Express Patient Monitor, Model PM-8000 Express (2006), 48 descendants of its own

## Recalls of this device
- Apr 5, 2004 · Not classified · Z-1050-04: Potential inaccurate printed information in the upper and lower margins of a print strip.

## Indications for use
The indications for use for the Passport 2™ include the monitoring of the following human physiological parameters: ECG waveform derived from 3 or 5 lead measurements Heart Rate derived from selected sources (SpO₂, ECG, IBP, NIBP) Blood Oxygenation (SpO₂) measurement/waveform ST Segment Analysis Lethal Arrhythmia Detection Non Invasive Blood Pressure (NIBP) measurement Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites Respiration Rate/ waveform derived from ECG or CO₂ CO₂, Inspired and end tidal mainstream/waveform Temperature measurement via Y SI 400/700 series probes The target populations are adult, pediatric and neonate with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations are adult and pediatric only. The monitor is intended for use in the health care facility setting. The Passport 2 has the capability of interfacing with Datascope’s Gas Module II, displaying the measurements of Anesthetic Gases, O₂, N₂O, and CO₂. * The Passport 2 monitors the SpO₂ parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an SpO₂ sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

Source page: https://510kreport.com/device/K993531
Methodology: https://510kreport.com/methodology