510(k) · Cleared
ClearedORG-9200A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 8, 2001 after a 216-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.
- Decided
- Feb 8, 2001
- Review
- 216 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK002068 ORG-9200ANihon Kohden America, Inc. · 2001
- Descendant · cites it directly · 16 of its ownK071058 Multiple Patient Receiver, Model Org-9700ANihon Kohden America, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 11 of its ownK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
- Descendant · 4 generations on · 4 of its ownK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK201949 Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series…Nihon Kohden Corporation · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K071058Multiple Patient Receiver, Model Org-9700ANihon Kohden America, Inc. · 2007 · cites it directly16descendants
- K080342Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008 · 2 generations on11descendants
- K082785Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008 · 3 generations on5descendants
- K151080Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · 4 generations on4descendants
- K201949Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM…Nihon Kohden Corporation · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002068 | ORG-9200A | Nihon Kohden America, Inc. | 2001 | — |
| +1 | K071058 | Multiple Patient Receiver, Model Org-9700A | Nihon Kohden America, Inc. | 2007 | 1 |
| +2 | K080342 | Nihon Kohden Bedside Monitor, Model BSM-6000S Series | Nihon Kohden America, Inc. | 2008 | — |
| +3 | K082785 | Nihon Kohden Bedside Monitor, BSM 9100A Series | Nihon Kohden America, Inc. | 2008 | — |
| +4 | K151080 | Nihon Kohden CSM 1901 Bedside Monitor | Nihon Kohden | 2015 | 1 |
| +3 | K201949 | Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life… | Nihon Kohden Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 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? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071058 | Multiple Patient Receiver, Model Org-9700A | 2007 | 16 |
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, K071058 (Nihon Kohden America, Inc., 2007) has gone furthest, with 16 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/K002068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002068: ORG-9200A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002068
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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