510(k) · Cleared
Recalled · Class II · 2018Dash 3000/4000 Patient Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · DSI Detector And Alarm, Arrhythmia
Cleared on Jul 18, 2000 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 303 devices in its family, counting itself, has a Class I recall. 302 later devices descend from it. It has been recalled once.
- Decided
- Jul 18, 2000
- Review
- 81 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 0
302 later devices descend from it, 2 citing it directly. 1 of the 303 devices in this family, counting this one, has a Class I recall.
- This deviceK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000
- Descendant · cites it directly · 284 of its ownK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- Descendant · 2 generations on · 257 of its ownK030431 Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- Descendant · 3 generations on · 238 of its ownK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
- Descendant · 4 generations on · 237 of its ownK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · Recalled
- Descendant · 5 generations on · 222 of its ownK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 302 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K133576 Monitor B405 generations on · 2014
Most influential descendants
Showing 5 of 302 · See all- K020290Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · cites it directly284descendants
- K030431Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · 2 generations on257descendants
- K042417Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004 · 3 generations on238descendants
- K053174Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · 4 generations on237descendants
- K060221The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006 · 5 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | — |
| +1 | K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2002 | 1 |
| +2 | K030431 | Modification to Dash 3000/4000 Patient Monitor | Ge Medical Systems Information Technologies | 2003 | 1 |
| +3 | K042417 | Zoll M Series ETC02 Loflo Option | Zoll Medical Corp | 2004 | — |
| +4 | K053174 | Loflo C5 CO2 Sensor | Respironics Novametrix, LLC | 2006 | 2 |
| +5 | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 10 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 8 | 0 |
| 2010 | 10 | 0 |
| 2011 | 9 | 0 |
| 2012 | 11 | 0 |
| 2013 | 18 | 0 |
| 2014 | 12 | 1 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 16 | 0 |
| 2018 | 15 | 0 |
| 2019 | 12 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 23 | 0 |
| 2023 | 24 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 0 |
| 2026 | 14 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (302)
See all 3022 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2018 | Class II | Z-0520-2019 | Software design | The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K133576Monitor B40Ge Medical Systems China Co., Ltd. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020290 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 284 descendants of its own.
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 | — |
https://510kreport.com/device/K001359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001359: Dash 3000/4000 Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001359
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026