510(k) · Cleared
ClearedCardiofax Ecg-6551 (Electrocardiogrph)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · DPS Electrocardiograph
Cleared on Sep 17, 1986 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Sep 17, 1986
- Review
- 34 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK863116 Cardiofax Ecg-6551 (Electrocardiogrph)Nihon Kohden America, Inc. · 1986
- Descendant · cites it directly · 22 of its ownK982470 Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998
- Descendant · 2 generations on · 21 of its ownK043361 Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005
- Descendant · 3 generations on · 18 of its ownK063044 Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007
- Descendant · 4 generations on · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- Descendant · 5 generations on · 13 of its ownK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K982470Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998 · cites it directly22descendants
- K043361Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005 · 2 generations on21descendants
- K063044Cardiobelt Electrode BeltMonebo Technologies, Inc. · 2007 · 3 generations on18descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · 4 generations on14descendants
- K110704SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863116 | Cardiofax Ecg-6551 (Electrocardiogrph) | Nihon Kohden America, Inc. | 1986 | — |
| +1 | K982470 | Ecg Electrodes Apron | Tapuz Medical Technology, Ltd. | 1998 | — |
| +2 | K043361 | Accuheart Electrode Belt | Advanced Bioelectric Corporation | 2005 | — |
| +3 | K063044 | Cardiobelt Electrode Belt | Monebo Technologies, Inc. | 2007 | — |
| +4 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| +5 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982470 | Ecg Electrodes Apron | 1998 | 22 |
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, K982470 (Tapuz Medical Technology, Ltd., 1998) has gone furthest, with 22 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
https://510kreport.com/device/K863116 · printed Nov 5, 2026
Cite this page
510(k) Report. “K863116: Cardiofax Ecg-6551 (Electrocardiogrph).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K863116
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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