510(k) · Cleared
Recalled · 2004Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · DSI Detector And Alarm, Arrhythmia
Cleared on Jan 13, 2000 as substantially equivalent to K972282 (Spacelabs Medical, Inc., 1997) and 6 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1994. 119 later devices descend from it. It has been recalled once.
- Decided
- Jan 13, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 3 generations to K933143 (1994). 23 ancestors in all, the oldest K842616 (1984). 119 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 2 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 1 generation backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- This deviceK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000
- Descendant · cites it directly · 88 of its ownK032733 PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004
- Descendant · 2 generations on · 87 of its ownK043348 Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- Descendant · cites it directly · 75 of its ownK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · Recalled
- Descendant · 3 generations on · 71 of its ownK053234 PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · Recalled
- Descendant · 3 generations on · 48 of its ownK053193 PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K032733PM-8000 Patient Monitor, Model 8000Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2004 · cites it directly88descendants
- K043348Modification to PM-8000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005 · 2 generations on87descendants
- K020550Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002 · cites it directly75descendants
- K053234PM-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 3 generations on71descendants
- K053193PM-8000 Express Patient Monitor, Model PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −2 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −1 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| 0 (this device) | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | — |
| +1 | K032733 | PM-8000 Patient Monitor, Model 8000 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2004 | — |
| +2 | K043348 | Modification to PM-8000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| +1 | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | 1 |
| +3 | K053234 | PM-9000 Express Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | 1 |
| +3 | K053193 | PM-8000 Express Patient Monitor, Model PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 10 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972282 | Spacelabs Medical Pcis Patient MonitorsSummary page 2…pares the performance specifications and functionality of the Passport 2 Vital Signs Monitor with those of several similar devices: the Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport SL-CE Vital Signs monitor (K97… | 1997 |
| * | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496Summary page 2…performance specifications and functionality of the Passport 2 Vital Signs Monitor with those of several similar devices: the Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport SL-CE Vital Signs monitor (K974178). The… | 1998 |
| * | K961139 | Eagle Patient Monitor Model 3000/3100Summary page 2…of the Passport 2 Vital Signs Monitor with those of several similar devices: the Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport SL-CE Vital Signs monitor (K974178). The functionality of the Passport 2 Vital Signs… | 1996 |
| * | K960272 | Eagle 3000/3100 Patient MonitorSummary page 2…ssport 2 Vital Signs Monitor with those of several similar devices: the Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport SL-CE Vital Signs monitor (K974178). The functionality of the Passport 2 Vital Signs monitor i… | 1996 |
| * | K960418 | Eagle Patient MonitorSummary page 2…ital Signs Monitor with those of several similar devices: the Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport SL-CE Vital Signs monitor (K974178). The functionality of the Passport 2 Vital Signs monitor is identica… | 1996 |
| * | K974178 | Passport 5L-CE Model 0998-00-0131XXXSummary page 2…e Spacelabs Ultraview 1050 Monitor (K972282 & K972502), Marquette Eagle 3000/3100 monitor (K961139, K960272 & K960418), and Datascope Passport SL-CE Vital Signs monitor (K974178). The functionality of the Passport 2 Vital Signs monitor is identical to that of the Spacelabs Ultraview 1050 monitor and Marque… | 1998 |
| * | K983575 | Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XXSummary page 2…as follows: 1. The NIBP measurement system used in the Passport 2 is the same as that used in Datascope’s Accutorr Plus NIBP monitor, cleared under 510(k) Notification K983575. 2. The SpO, measurement system used in the Passport 2 is the same as that used in the Masimo SET 2000 Pulse Oximeter, cleared u… | 1999 |
| † | K974903 | Gas Module II, Model 0998-00-0143 | 1998 |
| † | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | 1997 |
| † | K913576 | Datascope Model Visa Central Monitor | 1992 |
| † | K930548 | DPD Defibrillator | 1993 |
| † | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor… | 1999 |
What descends from it? (119)
See all 1194 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2004 | Not classified | Z-1050-04 | Other | Potential inaccurate printed information in the upper and lower margins of a print strip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K032733 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2004) has gone furthest, with 88 descendants of its own.
- 2 other devices also cite its predicate K972282.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (234 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993531
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026