510(k) · Cleared
ClearedEcg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M
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 Aug 30, 2007 as substantially equivalent to K052511 (Nihon Kohden America, Inc., 2006) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1999. 16 later devices descend from it.
- Decided
- Aug 30, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K984504 (1999). 2 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK984504 Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and AccessoriesNihon Kohden America, Inc. · 1999
- This deviceK072217 Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax MNihon Kohden America, Inc. · 2007
- Descendant · cites it directly · 13 of its ownK090367 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 10 of its ownK093869 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK131503 SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014
- Descendant · 4 generations on · 8 of its ownK160876 PC ECGEdan Instruments, Inc. · 2017
- Descendant · 5 generations on · 3 of its ownK171942 ElectrocardiographEdan Instruments, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K090367SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2009 · cites it directly13descendants
- K093869SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2010 · 2 generations on10descendants
- K131503SE-601 Series ElectrocardiographEdan Instruments, Inc. · 2014 · 3 generations on9descendants
- K160876PC ECGEdan Instruments, Inc. · 2017 · 4 generations on8descendants
- K171942ElectrocardiographEdan Instruments, Inc. · 2018 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984504 | Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories | Nihon Kohden America, Inc. | 1999 | — |
| 0 (this device) | K072217 | Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M | Nihon Kohden America, Inc. | 2007 | — |
| +1 | K090367 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2009 | 1 |
| +2 | K093869 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2010 | — |
| +3 | K131503 | SE-601 Series Electrocardiograph | Edan Instruments, Inc. | 2014 | — |
| +4 | K160876 | PC ECG | Edan Instruments, Inc. | 2017 | — |
| +5 | K171942 | Electrocardiograph | Edan Instruments, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052511 | Cardiofax CE, Model Ecg-1500 aSummary page 1…vice Classification Panel under 21 CFR Part 870.2340 Electrocardiograph per 74 LOS. *Legally Marketed Predicate: Nihon Kohden ECG- I150OA per 510(k) # 052511, commercial distribution certification dated May 24, 2006 and ECG-9130K per 5 10(k) #984504 commercial distribu… | 2006 |
| * | K984504 | Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and AccessoriesSummary page 1…y Marketed Predicate: Nihon Kohden ECG- I150OA per 510(k) # 052511, commercial distribution certification dated May 24, 2006 and ECG-9130K per 5 10(k) #984504 commercial distribution certification dated April 15, 1999. Intended Use: The Nihon Kohden ECG-1250A and ECG-1350A devices are i… | 1999 |
What descends from it? (16)
See all 163 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K090367 (Edan Instruments, Inc., 2009) has gone furthest, with 13 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. 2007, this device’s year, is highlighted.
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 ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are intended to monitor the patient's heart rate electrically, the devices have been developed as the devices to select the operators, amplify, record or measure the electric potential captured by the electrodes attached to the patient's thoracic and extremities parts. Based on the information output by the devices, the devices will help the doctors for their…
Read the full statement (168 words)
The ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are intended to monitor the patient's heart rate electrically, the devices have been developed as the devices to select the operators, amplify, record or measure the electric potential captured by the electrodes attached to the patient's thoracic and extremities parts. Based on the information output by the devices, the devices will help the doctors for their cardiovascular diagnostication.
For non-interpretive applications, the ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M Electrocardiographs are 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 are 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. Qualified physicians trained in electrocardiography recommend all assessments provided by the interpretation programs for review.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072217 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072217: Ecg-1250A Series Cardiofax S and Ecg-1350A Series Cardiofax M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072217
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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