510(k) · Cleared
ClearedFukuda Denshi Dynascope Model DS-5700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 6, 2002 as substantially equivalent to K000746 (Fukuda Denshi USA, Inc., 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 6, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000746 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000746 Fukuda Denshi Dynascope, Model DS-5800NXFukuda Denshi USA, Inc. · 2000
- This deviceK020084 Fukuda Denshi Dynascope Model DS-5700Fukuda Denshi USA, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000746 | Fukuda Denshi Dynascope, Model DS-5800NX | Fukuda Denshi USA, Inc. | 2000 | — |
| 0 (this device) | K020084 | Fukuda Denshi Dynascope Model DS-5700 | Fukuda Denshi USA, Inc. | 2002 | — |
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? (2)
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 |
|---|---|---|---|
| * | K000746 | Fukuda Denshi Dynascope, Model DS-5800NXSummary page 2…ion Exhibit B 510(k) Summary Legally Marketed Device: Description: Intended Use: Special 510(k) Fukuda Denshi DynaScope model DS-5800 NXMB Central Monitor Station: K000746 The DS-5700 is a microprocessor based software controlled device. The system consist of a central station includes a freestandin… | 2000 |
| * | — | Fukuda Denshi model DS-5300NXMB Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
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?
Use of the DS-5700 is indicated in those situations where centrally located hemodynamic monitoring of one or more patient’s cardiovascular condition is desired and those patients are currently monitored at bedside by a Fukuda Denshi DS-5000 series bedside monitor. Use of this device is indicated only in a medically supervised healthcare environment. It is not for home use.
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/K020084 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020084: Fukuda Denshi Dynascope Model DS-5700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020084
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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