510(k) · Cleared
ClearedFukuda Denshi Model FCP-4101
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 Dec 9, 1991 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 9, 1991
- Review
- 105 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK913811 Fukuda Denshi Model FCP-4101Fukuda Denshi USA, Inc. · 1991
- Descendant · cites it directly · 3 of its ownK971440 Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive…Fukuda Denshi USA, Inc. · 1997
- Descendant · 2 generations on · 2 of its ownK981066 Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel…Fukuda Denshi USA, Inc. · 1998
- Descendant · 3 generations on · 0 of its ownK173226 CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K971440Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive ElectrocardiographFukuda Denshi USA, Inc. · 1997 · cites it directly3descendants
- K981066Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographFukuda Denshi USA, Inc. · 1998 · 2 generations on2descendants
- K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018 · 3 generations on0descendants
- K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K981066 | Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph | Fukuda Denshi USA, Inc. | 1998 | — |
| +3 | K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | 2018 | — |
| +3 | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971440 | Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph | 1997 | 3 |
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, K971440 (Fukuda Denshi USA, Inc., 1997) has gone furthest, with 3 descendants of its own.
https://510kreport.com/device/K913811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913811: Fukuda Denshi Model FCP-4101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913811
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026