510(k) Report

510(k) · Cleared

Cleared

Fukuda Denshi Model DS-5100E Portable Patient Monitor

K971131510(k) TraditionalCleared Oct 3, 1997190-day reviewClass II21 CFR 870.1025

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. · DSI Detector And Alarm, Arrhythmia

Cleared on Oct 3, 1997 as substantially equivalent to K964187 (Fukuda Denshi USA, Inc., 1997) after a 190-day review. Its family tree reaches back 2 generations to 1990. 6 later devices descend from it.

Decided
Oct 3, 1997
Review
190 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K894628 (1990). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2015: 2 descendants clearedK894628 · Model DS-3300 Dynascope Patient Monitor · Fukuda Denshi USA, Inc. · 1990K964187 · Fukada Denshi Dynascope Model DS-5300 Patient Monitor · Fukuda Denshi USA, Inc. · 19971990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants K964187 · Fukada Denshi Dynascope Model DS-5300 Patient Monitor · Fukuda Denshi USA, Inc. · 1997K894628 · Model DS-3300 Dynascope Patient Monitor · Fukuda Denshi USA, Inc. · 19900+5
  1. Root · 2 generations backK894628 Model DS-3300 Dynascope Patient MonitorFukuda Denshi USA, Inc. · 1990
  2. 1 generation backK964187 Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc. · 1997
  3. This deviceK971131 Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc. · 1997
  4. Descendant · cites it directly · 5 of its ownK032290 Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003
  5. Descendant · 2 generations on · 4 of its ownK040246 Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004
  6. Descendant · 3 generations on · 3 of its ownK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
  7. Descendant · 4 generations on · 2 of its ownK083697 Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009
  8. Descendant · 5 generations on · 0 of its ownK150030 Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12008: 12009: 12015: 2
2003high 2 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K032290Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003 · cites it directly5descendants
  • K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004 · 2 generations on4descendants
  • K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008 · 3 generations on3descendants
  • K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009 · 4 generations on2descendants
  • K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K894628Model DS-3300 Dynascope Patient MonitorFukuda Denshi USA, Inc.1990—
−1K964187Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc.1997—
0 (this device)K971131Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc.1997—
+1K032290Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc.2003—
+2K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc.2004—
+3K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.2008—
+4K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc.2009—
+5K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200810
200910
201520
FIG. 1 — Lineage of K971131, 1990–2015Source: 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 DSI? 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 DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K964187Fukada Denshi Dynascope Model DS-5300 Patient Monitor
Cleared while this submission was under review
Summary page 1
…n Name: Portable Patient Monitor Classification Name: Arrhythmia detector and alarm Legally Marketed Device: FUKUDA DENSHI model DS-5300 Patient Monitor, 510(k) number K964187. (The DS-5100E is a modification to the DS-5300, 510(k) number K964187.) July 3, 1997 DS-5100E 510(k) Additional Information K9…
Fukuda Denshi USA, Inc.1997—

Also cleared against K964187: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K032290Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc.20035

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 7.3 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K032290 (Fukuda Denshi USA, Inc., 2003) has gone furthest, with 5 descendants of its own.
  • 3 other devices also cite its predicate K964187.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

What is it indicated for?

Use of the Fukuda Denshi model DS-5100E Portable Patient Monitor system is indicated in those clinical settings where Observations of one or more of the following parameters on an individual patient may be required: ECG (waveform, heart rate, ST-Level, and ventricular arrhythmias), respiration, non-invasive and/or invasive blood pressures, temperature, and/or pulse oximetry. The observations may include an audible and visual alarm if any of these…

Read the full statement (143 words)

Use of the Fukuda Denshi model DS-5100E Portable Patient Monitor system is indicated in those clinical settings where

Observations of one or more of the following parameters on an individual patient may be required: ECG (waveform, heart rate, ST-Level, and ventricular arrhythmias), respiration, non-invasive and/or invasive blood pressures, temperature, and/or pulse oximetry.

The observations may include an audible and visual alarm if any of these parameters exceed values that are establish by the clinician.

The observations may also include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours.

An instantaneous display of waveforms, numeric, and trended values is desired.

a hard copy record of the physiological parameters, the alarmed conditions, or the trended values may be required.

where the patient may need to be monitored while being transported within the healthcare facility.

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

Also cleared against K964187

3 other devices cite the same predicate.

  • K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc. · 2015
  • K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc. · 2011
  • K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008

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 DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K971131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971131: Fukuda Denshi Model DS-5100E Portable Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971131

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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