510(k) Report

510(k) · Cleared

Cleared

Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph

K971440510(k) TraditionalCleared Dec 2, 1997228-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fukuda Denshi USA, Inc. · LOS (no longer in FDA’s product-code list)

Cleared on Dec 2, 1997 as substantially equivalent to K913811 (Fukuda Denshi USA, Inc., 1991) after a 228-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it.

Decided
Dec 2, 1997
Review
228 days
Product code
LOS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K913811 (1991). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2015: 1 descendant cleared2018: 1 descendant clearedK913811 · Fukuda Denshi Model FCP-4101 · Fukuda Denshi USA, Inc. · 19911990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants K913811 · Fukuda Denshi Model FCP-4101 · Fukuda Denshi USA, Inc. · 19910
  1. Root · 1 generation backK913811 Fukuda Denshi Model FCP-4101Fukuda Denshi USA, Inc. · 1991
  2. This deviceK971440 Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive…Fukuda Denshi USA, Inc. · 1997
  3. Descendant · cites it directly · 2 of its ownK981066 Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel…Fukuda Denshi USA, Inc. · 1998
  4. Descendant · 2 generations on · 0 of its ownK173226 CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018
  5. Descendant · 2 generations on · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015

Most influential descendants

Showing 3 of 3 · See all
  • K981066Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographFukuda Denshi USA, Inc. · 1998 · cites it directly2descendants
  • K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018 · 2 generations on0descendants
  • K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913811Fukuda Denshi Model FCP-4101Fukuda Denshi USA, Inc.1991—
0 (this device)K971440Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive ElectrocardiographFukuda Denshi USA, Inc.1997—
+1K981066Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographFukuda Denshi USA, Inc.1998—
+2K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc.2018—
+2K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
201510
201810
FIG. 1 — Lineage of K971440, 1991–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K913811Fukuda Denshi Model FCP-4101
Summary page 1
…ocardiograph Common Name: Multi Channel, Interpretive Electrocardiograph Classification Name: Electrocardiograph Legally Marketed Device: FCP-4101 Interpretative EKG, K913811 FCP-2155 510(k) Additional Information K971440 November 25, 1997 Section 2-B.doc : Page 1 of 4 Description: DEC…
Fukuda Denshi USA, Inc.1991—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981066Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographFukuda Denshi USA, Inc.19982

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?

  • Its one ancestor has no recall.
  • Of its descendants, K981066 (Fukuda Denshi USA, Inc., 1998) has gone furthest, with 2 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 FCP-2155 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. This device is indicated where…

Read the full statement (167 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 FCP-2155 is indicated where a clinician seeks advisory interpretive measurement, and diagnostic statements that would require confirmation by a physician. This device is indicated where the clinician seeks R to R timing measurements and trend information.

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.

The FCP-2155 may be operated from battery or AC power

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fukuda Denshi USA, Inc.

68 FDA decisions under this applicant name. See the company

  • K173226CardiMax ElectrocardiographFukuda Denshi USA, Inc. · 2018
  • K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
  • K134046Fukuda Denshi Dynascope Model DS-8100N/8100M Patient MonitorFukuda Denshi USA, Inc. · 20152 recalls
  • K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc. · 2011
  • K103134Fukuda DenshiFukuda Denshi USA, Inc. · 2011

Recent decisions in LOS

The LOS category page

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  • K083749CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC · 2009
  • K073376Philips Ecg AlgorithmPhilips Medical Systems · 2008
  • K023034Cardiotouch-3000Bionet Company, Ltd. · 2002
  • K011328Cardio Care Ekg-2000 12-Channel ElectrocardiographBionet Company, Ltd. · 2001

https://510kreport.com/device/K971440 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971440: Fukuda Denshi Model FCP-2155 Multi Channel, Interpretive Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971440

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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