# K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Aug 28, 2002 after 190 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: 4 generations back to K933143 (1994). 24 ancestors in all.
75 later devices descend from it; 5 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX, Datascope Corp. (2000) Summary page 2.
- 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.

## Most influential descendants
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express (2007), 47 descendants of its own
- K072581: PM-60 Pulse Oximeter (2008), 19 descendants of its own
- K072346: PM-7000 Patient Monitor (2007), 19 descendants of its own
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 (2010), 16 descendants of its own
- K062144: Escort M8 Vital Signs Patient Monitor, Model 3810 (2006), 11 descendants of its own

## Recalls of this device
- Sep 7, 2005 · Not classified · Z-0177-06: Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data.

## Indications for use
The indications for use for the Passport 2 with View 12 ECG Analysis Module include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5 or 12 lead measurements Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP) Blood Oxygenation (SpO2) measurement/waveform ST Segment Analysis derived from 5 or 12 lead measurements Lethal Arrhythmia Detection derived from 5 or 12 lead measurements Non Invasive Blood Pressure (NIBP) measurement Invasive Blood Pressure (BP) measurement/waveform measurable at two sites Respiration Rate/waveform derived from ECG or CO2 CO2, Inspired and end tidal microstream/waveform Temperature measurement via YSI 400/700 series probes Interpretation of Resting 12 lead ECG 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, and Interpretation of Resting 12 Lead ECG, for which the target population is adult only. The monitor is intended for use in the health care facility setting. The device has the capability of interfacing with Datascope’s Gas Module II, displaying the measurements of Anesthetic Gases, O2, N2O, and CO2. * The device 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/K020550
Methodology: https://510kreport.com/methodology