510(k) · Cleared
ClearedNihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden America, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Apr 15, 1999 after a 118-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Apr 15, 1999
- Review
- 118 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 1 citing it directly.
- This deviceK984504 Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and AccessoriesNihon Kohden America, Inc. · 1999
- 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) | K984504 | Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories | Nihon Kohden America, Inc. | 1999 | — |
| +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 LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | ECG-9320A Named without a submission 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.
What is it indicated for?
The ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart. For non-interpretive applications, the ECG-9110K and ECG-9130K are intended for use with a full range of patient populations as determined by a clinician. The…
Read the full statement (136 words)
The ECG-9110K and ECG-9130K Cardiofax Q electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart.
For non-interpretive applications, the ECG-9110K and ECG-9130K are intended for use with a full range of patient populations as determined by a clinician. The devices also provide an mterpretlve ECG program mtended for use with patients age 3 years to adult.
The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physicidn in diagnosis. Assessments provided by the interpretation program are not intended as the solg basis for diagnosis. All assessments provided by the interpretation program are recommended Tor review by qualified physicians trained in electrocardiography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984504: Nihon Kohden Ecg-9110K and Ecg-9130K Cardiofax Q and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984504
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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