# K974178: Passport 5L-CE Model 0998-00-0131XXX

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Jun 26, 1998 after 232 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
120 later devices descend from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), 119 descendants of its own
- 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

## Indications for use
The indications for use for the Passport 5L-CE Monitor include the monitoring of the following human physiological vital signs: Blood Oxygenation (SpO,) measurement/waveform ECG waveform derived from 3 or 5 Lead measurements Respiration rate/waveform derived from ECG or CO, Temperature measurement via YSI 400/700 series probes Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites Non Invasive Blood Pressure (NIBP) measurement CO,, Inspired and end tidal mainstream/waveform Heart Rate derived from selected source ((SpO,, ECG, IBP, NIBP)

Source page: https://510kreport.com/device/K974178
Methodology: https://510kreport.com/methodology