510(k) · Cleared
ClearedFukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fukuda Denshi USA, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Aug 31, 1998 as substantially equivalent to K971440 (Fukuda Denshi USA, Inc., 1997) after a 160-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Aug 31, 1998
- Review
- 160 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913811 (1991). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913811 Fukuda Denshi Model FCP-4101Fukuda Denshi USA, Inc. · 1991
- 1 generation backK971440 Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive…Fukuda Denshi USA, Inc. · 1997
- This deviceK981066 Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel…Fukuda Denshi USA, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK173226 CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913811 | Fukuda Denshi Model FCP-4101 | Fukuda Denshi USA, Inc. | 1991 | — |
| −1 | K971440 | Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph | Fukuda Denshi USA, Inc. | 1997 | — |
| 0 (this device) | K981066 | Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph | Fukuda Denshi USA, Inc. | 1998 | — |
| +1 | K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | 2018 | — |
| +1 | K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K971440 | Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive ElectrocardiographSummary page 1…Common Name: Multi Channel Interpretive Electrocardiograph Classification Name: Electrocardiograph Legally Marketed Device: FCP-2155, Multi Channel Interpretative ECG (K971440) FX4010 Reve Additional Information 03/18/98 40102a Page 1 of § ) Description: Intended. Usefi The Fukuda Densh… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173226 (Fukuda Denshi USA, Inc., 2018) has gone furthest, with 0 descendants of its own.
What is it indicated for?
Use of this device is indicated where a physician or healthcare professional requires information about the electrical events within the myocardium using waveforms recorded from the body’s surface during depolarization and repolarization of the atrium and ventricles. The FX-4010 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. Also, can provide measurement…
Read the full statement (161 words)
Use of this device is indicated where a physician or healthcare professional requires information about the electrical events within the myocardium using waveforms recorded from the body’s surface during depolarization and repolarization of the atrium and ventricles. The FX-4010 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. Also, can provide measurement data, R to R timing measurements with trend infotmation and interpretation of arrhythmia to the clinician.
The basic EKG and recording features of this device are intended to be used on any patient; neonate, pediatric, or adult; where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. The interpretive feature of this device is intended to be used on any patient, at least one (1) year old, where the placement of EKG electrodes does not interfere with or complicate the treatment of the patient. This device is not intended for home use.
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/K981066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981066: Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981066
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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