510(k) · Cleared
Recalled · 2005Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX
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 Aug 28, 2002 as substantially equivalent to K993531 (Datascope Corp., 2000) and 2 other predicates after a 190-day review. Its family tree reaches back 4 generations to 1994. 75 later devices descend from it. It has been recalled once.
- Decided
- Aug 28, 2002
- Review
- 190 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K933143 (1994). 24 ancestors in all, the oldest K842616 (1984). 75 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 3 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 2 generations backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- 1 generation backK993531 Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXDatascope Corp. · 2000 · Recalled
- This deviceK020550 Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXXDatascope Corp. · 2002
- Descendant · cites it directly · 47 of its ownK070791 PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 2 generations on · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 2 generations on · 19 of its ownK072346 PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 3 generations on · 16 of its ownK100046 M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010
- Descendant · cites it directly · 11 of its ownK062144 Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K070791PM Series Patient Monitors, Models PM-9000 Express and PM-8000 ExpressShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · cites it directly47descendants
- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on19descendants
- K072346PM-7000 Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on19descendants
- K100046M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000Guangdong Biolight Meditech Co., Ltd. · 2010 · 3 generations on16descendants
- K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation · 2006 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −3 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −2 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| −1 | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX | Datascope Corp. | 2000 | 1 |
| 0 (this device) | K020550 | Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX | Datascope Corp. | 2002 | — |
| +1 | K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +2 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +2 | K072346 | PM-7000 Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +3 | K100046 | M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010 | — |
| +1 | K062144 | Escort M8 Vital Signs Patient Monitor, Model 3810 | Invivo Corporation | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-XXSummary page 2…Class I11 Legally Marketed Predicate Devices: The View 12 ECG Analysis Module is an addition to the existing Passport 2 Vital Signs Monitor (K99353 1). This submission compares the performance specifications and functionality of the Passport 2 Vital Signs Monitor with Vi… | 2000 |
| * | K972282 | Spacelabs Medical Pcis Patient MonitorsSummary page 2…specifications and functionality of the Passport 2 Vital Signs Monitor with View 12 ECG Analysis Module to those of the Spacelabs Ultraview 1050 Monitor (K972282) equipped with Integrated Multiparameter Module 90496 (K972502). The functionality of the Passport 2 Vital Signs… | 1997 |
| * | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496Summary page 2…Monitor with View 12 ECG Analysis Module to those of the Spacelabs Ultraview 1050 Monitor (K972282) equipped with Integrated Multiparameter Module 90496 (K972502). The functionality of the Passport 2 Vital Signs monitor with View 12 ECG Analysis Module is identical to that of the Sp… | 1998 |
| † | K920627 | Model Eli 100 Electrocardiograph | 1992 |
| † | K933143 | Model Eli 300 Electrocardiograph | 1994 |
| † | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor… | 1999 |
What descends from it? (75)
See all 755 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070791 | PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express | 2007 | 47 |
| K062144 | Escort M8 Vital Signs Patient Monitor, Model 3810 | 2006 | 11 |
| K031849 | Spectrum Patient Monitor, Model 0998-00-0500-Xxxxx | 2003 | 9 |
| K101619 | Welch Allyn 1500 Patient Monitor | 2010 | 4 |
| K090443 | Planet 55, Model 100 | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2005 | Not classified | Z-0177-06 | Other | Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-Lead ECG data. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K070791 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2007) has gone furthest, with 47 descendants of its own.
- 3 other devices also cite its predicate K993531.
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 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…
Read the full statement (272 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020550 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020550
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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