510(k) Report

510(k) · Cleared

Cleared

Fukada Denshi Dynascope Model DS-5300 Patient Monitor

K964187510(k) TraditionalCleared May 1, 1997192-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 May 1, 1997 as substantially equivalent to K894628 (Fukuda Denshi USA, Inc., 1990) after a 192-day review. Its family tree reaches back 1 generation to 1990. 8 later devices descend from it.

Decided
May 1, 1997
Review
192 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K894628 (1990). 8 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2015: 2 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2003: 1 descendant cleared2004: 1 descendant clearedReference device: K901889 · Fukuda Denshi Model HJ-310 · Fukuda Denshi USA, Inc. · 1990Reference device: K945464 · Fukuda Denshi Mode HG-302 Pulse Oximeter Module · Fukuda Denshi USA, Inc. · 1995K894628 · Model DS-3300 Dynascope Patient Monitor · Fukuda Denshi USA, Inc. · 19901990200020102020
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K894628 · Model DS-3300 Dynascope Patient Monitor · Fukuda Denshi USA, Inc. · 19900
  1. Root · 1 generation backK894628 Model DS-3300 Dynascope Patient MonitorFukuda Denshi USA, Inc. · 1990
  2. This deviceK964187 Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc. · 1997
  3. Descendant · cites it directly · 6 of its ownK971131 Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc. · 1997
  4. Descendant · 2 generations on · 5 of its ownK032290 Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003
  5. Descendant · 3 generations on · 4 of its ownK040246 Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004
  6. Descendant · cites it directly · 3 of its ownK081891 Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008
  7. Descendant · 2 generations on · 2 of its ownK083697 Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1997: 12003: 12004: 12008: 12009: 12011: 12015: 2
1997high 2 (2015) · low 0 (1998)2026

Most influential descendants

Showing 5 of 8 · See all
  • K971131Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc. · 1997 · cites it directly6descendants
  • K032290Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient MonitorFukuda Denshi USA, Inc. · 2003 · 2 generations on5descendants
  • K040246Fukuda Denshi Dynascope Model DS-7141 Portable Patient MonitorFukuda Denshi USA, Inc. · 2004 · 3 generations on4descendants
  • K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008 · cites it directly3descendants
  • K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model…Fukuda Denshi USA, Inc. · 2009 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200310
200410
200810
200910
201110
201520
FIG. 1 — Lineage of K964187, 1990–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K894628Model DS-3300 Dynascope Patient Monitor
Summary page 1
…or Common Name: Patient Monitor Classification Name: Arrhythmia detector and alarm Legally Marketed Device: FUKUDA DENSHI model DS-3300 Patient Monitor, 510(k) number K894628. (Also references FUKUDA DENSHI model HB-310, 510(k) number K901889, and FUKUDA DENSHI model HG-302, 510(k) number K945464. These…
Fukuda Denshi USA, Inc.1990—
†K901889Fukuda Denshi Model HJ-310Fukuda Denshi USA, Inc.1990—
†K945464Fukuda Denshi Mode HG-302 Pulse Oximeter ModuleFukuda Denshi USA, Inc.1995—

Also cleared against K894628: 1 other device →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971131Fukuda Denshi Model DS-5100E Portable Patient MonitorFukuda Denshi USA, Inc.19976
K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc.20083
K150030Fukuda Denshi DynaScope Model DS-8000 Series Patient MonitorFukuda Denshi USA, Inc.20150
K112521Fukuda Denshi Vasera Model VS-1500Fukuda Denshi USA, Inc.20110

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, K971131 (Fukuda Denshi USA, Inc., 1997) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K894628.

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 model DS-5300 Patient Monitor provides a simple and reliable method to display and document the continuos hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients; neonate, pediatric, and adult; may be located in a hospital ICU, CCU, OR, ER, recovery, or other critical care unit. The DS-5300 can also be used to follow patients whose treatment requires close observation of specific…

Read the full statement (123 words)

The Fukuda Denshi model DS-5300 Patient Monitor provides a simple and reliable method to display and document the continuos hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients; neonate, pediatric, and adult; may be located in a hospital ICU, CCU, OR, ER, recovery, or other critical care unit. The DS-5300 can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients may be in a clinic or other healthcare environment under the care of a physician. Parameters such as ECG, respiration, non-invasive or invasive blood pressures, temperature, pulse oximetry, and cardiac output may be monitored individually or in any grouping required by the clinician. 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.

Also cleared against K894628

1 other device cites the same predicate.

  • K970585Fukuda Denshi Dynascope Model DS-5800 Central Station MonitorFukuda Denshi USA, Inc. · 1997

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/K964187 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964187: Fukada Denshi Dynascope Model DS-5300 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/K964187

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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