510(k) Report

510(k) · Cleared

Cleared

Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System

K980728510(k) TraditionalCleared Jun 19, 1998114-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 Jun 19, 1998 as substantially equivalent to K897063 (Fukuda Denshi USA, Inc., 1990) and 2 other predicates after a 114-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.

Decided
Jun 19, 1998
Review
114 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K897063 (1990). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1992: 1 other ancestor2004: 1 descendant cleared2011: 1 descendant clearedK897063 · Fukuda Denshi Model DS-3300 Etr · Fukuda Denshi USA, Inc. · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K897063 · Fukuda Denshi Model DS-3300 Etr · Fukuda Denshi USA, Inc. · 19900
  1. Root · 1 generation backK897063 Fukuda Denshi Model DS-3300 EtrFukuda Denshi USA, Inc. · 1990
  2. This deviceK980728 Fukuda Denshi Dynascope Model DS-5000 Series Telemetry SystemFukuda Denshi USA, Inc. · 1998
  3. Descendant · cites it directly · 1 of its ownK033711 Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc. · 2004
  4. Descendant · 2 generations on · 0 of its ownK103134 Fukuda DenshiFukuda Denshi USA, Inc. · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K033711Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc. · 2004 · cites it directly1descendant
  • K103134Fukuda DenshiFukuda Denshi USA, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K897063Fukuda Denshi Model DS-3300 EtrFukuda Denshi USA, Inc.1990—
0 (this device)K980728Fukuda Denshi Dynascope Model DS-5000 Series Telemetry SystemFukuda Denshi USA, Inc.1998—
+1K033711Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc.2004—
+2K103134Fukuda DenshiFukuda Denshi USA, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201110
FIG. 1 — Lineage of K980728, 1990–2011Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K897063Fukuda Denshi Model DS-3300 Etr
Summary page 1
…Series Telemetry System Central Telemetry System Arrhythmia Detector and Alarm (§870.1025) Legally Marketed Device: Fukuda Denshi model DS-3300 ETR Telemetry System (K897063) Fukuda Denshi model LX-3240 (K963057) Nihon Kohden BSM-2100A (K914092) DS-5000 Telemetry System 510(k) Submittal 02/23/98 Sect…
Fukuda Denshi USA, Inc.1990—
*K963057Fukuda Denshi Model LX-3240 Ecg & Respiratory Transmitter
Summary page 1
…etry System Arrhythmia Detector and Alarm (§870.1025) Legally Marketed Device: Fukuda Denshi model DS-3300 ETR Telemetry System (K897063) Fukuda Denshi model LX-3240 (K963057) Nihon Kohden BSM-2100A (K914092) DS-5000 Telemetry System 510(k) Submittal 02/23/98 Section 2.doc Page 1 of 7…
Fukuda Denshi USA, Inc.1997—
*K914092BSM-2100A Configured Patient Monitor
Summary page 1
…and Alarm (§870.1025) Legally Marketed Device: Fukuda Denshi model DS-3300 ETR Telemetry System (K897063) Fukuda Denshi model LX-3240 (K963057) Nihon Kohden BSM-2100A (K914092) DS-5000 Telemetry System 510(k) Submittal 02/23/98 Section 2.doc Page 1 of 7 Description: The DS-5000 Series…
Nihon Kohden America, Inc.1992—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K033711Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc.20041

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K033711 (Fukuda Denshi USA, Inc., 2004) has gone furthest, with 1 descendant of its own.

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?

The Fukuda Denshi DS-5000 series Telemetry Monitoring system is indicated in those situations where centrally located hemodynamic monitoring (central station monitoring) of one or more patients’s cardiovascular condition is desired and those patients are currently monitored by a Fukuda Denshi DS-5000 series bedside monitor, or is wearing a Fukuda Denshi telemetry transmitter. Use of this device is indicated only in a medically supervised healthcare environment (e.g., ER, ICU, or clinic). Itis 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.

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/K980728 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980728: Fukuda Denshi Dynascope Model DS-5000 Series Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980728

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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