510(k) · Cleared
ClearedModel DS-3300 Dynascope Patient Monitor
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 Jan 8, 1990 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jan 8, 1990
- Review
- 168 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK894628 Model DS-3300 Dynascope Patient MonitorFukuda Denshi USA, Inc. · 1990
- Descendant · cites it directly · 8 of its ownK964187 Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc. · 1997
- Descendant · 2 generations on · 6 of its ownK971131 Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc. · 1997
- Descendant · 3 generations on · 5 of its ownK032290 Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003
- Descendant · 4 generations on · 4 of its ownK040246 Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K964187Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc. · 1997 · cites it directly8descendants
- K971131Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc. · 1997 · 2 generations on6descendants
- K032290Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003 · 3 generations on5descendants
- K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004 · 4 generations on4descendants
- K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894628 | Model DS-3300 Dynascope Patient Monitor | Fukuda Denshi USA, Inc. | 1990 | — |
| +1 | K964187 | Fukada Denshi Dynascope Model DS-5300 Patient Monitor | Fukuda Denshi USA, Inc. | 1997 | — |
| +2 | K971131 | Fukuda Denshi Model DS-5100E Portable Patient Monitor | Fukuda Denshi USA, Inc. | 1997 | — |
| +3 | K032290 | Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor | Fukuda Denshi USA, Inc. | 2003 | — |
| +4 | K040246 | Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor | Fukuda Denshi USA, Inc. | 2004 | — |
| +2 | K081891 | Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor | Fukuda Denshi USA, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964187 (Fukuda Denshi USA, Inc., 1997) has gone furthest, with 8 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/K894628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894628: Model DS-3300 Dynascope Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894628
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026