510(k) · Cleared
ClearedCardiofax-V Ecg-834OA
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 Mar 10, 1987 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Mar 10, 1987
- Review
- 77 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK865032 Cardiofax-V Ecg-834OANihon Kohden America, Inc. · 1987
- Descendant · cites it directly · 1 of its ownK972310 Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden…Nihon Kohden America, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK072060 QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax VNihon Kohden America, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK961272 Nihon Kohden Ecg-9320A Cardiofax and AccessoriesNihon Kohden America, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K972310Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax…Nihon Kohden America, Inc. · 1997 · cites it directly1descendant
- K072060QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax VNihon Kohden America, Inc. · 2007 · 2 generations on0descendants
- K961272Nihon Kohden Ecg-9320A Cardiofax and AccessoriesNihon Kohden America, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K865032 | Cardiofax-V Ecg-834OA | Nihon Kohden America, Inc. | 1987 | — |
| +1 | K972310 | Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a… | Nihon Kohden America, Inc. | 1997 | — |
| +2 | K072060 | QP-156E Ecg Exercise Test Option for the Ecg-1500A Series/Cardiofax V | Nihon Kohden America, Inc. | 2007 | — |
| +1 | K961272 | Nihon Kohden Ecg-9320A Cardiofax and Accessories | Nihon Kohden America, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2007 | 1 | 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? (3)
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, K972310 (Nihon Kohden America, Inc., 1997) has gone furthest, with 1 descendant 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/K865032 · printed Nov 4, 2026
Cite this page
510(k) Report. “K865032: Cardiofax-V Ecg-834OA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K865032
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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