510(k) · Cleared
ClearedCardiofax CE, Model Ecg-1500 a
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 May 24, 2006 after a 252-day review. The FDA summary names no predicate by number. 17 later devices descend from it.
- Decided
- May 24, 2006
- Review
- 252 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK052511 Cardiofax CE, Model Ecg-1500 aNihon Kohden America, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK072217 Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MNihon Kohden America, Inc. · 2007
- Descendant · 2 generations on · 13 of its ownK090367 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 10 of its ownK093869 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010
- Descendant · 4 generations on · 9 of its ownK131503 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014
- Descendant · 5 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K072217Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MNihon Kohden America, Inc. · 2007 · cites it directly16descendants
- K090367SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2009 · 2 generations on13descendants
- K093869SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010 · 3 generations on10descendants
- K131503SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014 · 4 generations on9descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052511 | Cardiofax CE, Model Ecg-1500 a | Nihon Kohden America, Inc. | 2006 | — |
| +1 | K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M | Nihon Kohden America, Inc. | 2007 | — |
| +2 | K090367 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2009 | 1 |
| +3 | K093869 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
| +4 | K131503 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2014 | — |
| +5 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M | 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, K072217 (Nihon Kohden America, Inc., 2007) has gone furthest, with 16 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 | — |
What is it indicated for?
The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer. For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician. The…
Read the full statement (137 words)
The Cardiofax V electrocardiograph is intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a patient record (monitor and recorder) and prepare a record and/or provide wireless transmission of data to a remote printer and/or computer.
For non-interpretive applications, the device is intended for use with a full range of patient populations as determined by a clinician.
The devices also provide an interpretive ECG program intended for use with patients age 3 years and older. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052511: Cardiofax CE, Model Ecg-1500 a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052511
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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