510(k) Report

FDA applicant

Fukuda Denshi USA, Inc.

Redmond, WA68 decisions1984–20182 recalls

FDA records 68 decisions for Fukuda Denshi USA, Inc. (Redmond, WA) from 1984 to 2018: 68 510(k) clearances. Most are in product codes DSI (Detector And Alarm, Arrhythmia) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 48 predicates, 30 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Fukuda Denshi USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008: 22009: 12011: 22015: 22018: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2015: 12017: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Fukuda Denshi USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fukuda Denshi USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DSIDetector And Alarm, Arrhythmia19decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)8decisions
  • DPSElectrocardiograph7decisions
  • BZGSpirometer, Diagnostic4decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic4decisions
  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)4decisions

Also: LOS (4), IYN (3), DQA (3), DXN (3), CCK (2), DSF (2).

Whose devices does it build on?

Its devices cite 48 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 30 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K964187Fukada Denshi Dynascope Model DS-5300 Patient MonitorFukuda Denshi USA, Inc. · 19974cite it
  • K922208Fukuda Denshi Model UF-4500Fukuda Denshi USA, Inc. · 19933cite it
  • K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210MFukuda Denshi USA, Inc. · 20092cite it
  • K894628Model DS-3300 Dynascope Patient MonitorFukuda Denshi USA, Inc. · 19902cite it
  • K981066Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel ElectrocardiographFukuda Denshi USA, Inc. · 19982cite it
  • K033209Fukuda Denshi Model FF Sonic UF-750XTFukuda Denshi USA, Inc. · 20032cite it

What has FDA decided for it lately?

  • 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
  • K083697Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210MFukuda Denshi USA, Inc. · 2009
  • K082656Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging UnitFukuda Denshi USA, Inc. · 2008
  • K081891Fukuda Denshi Dynascope Model DS-7000/7000M Patient MonitorFukuda Denshi USA, Inc. · 2008

All 68 as Fukuda Denshi USA, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K134046Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the…Oct 16, 2017Class II
  • K134046Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope…Dec 21, 2015Class II

Other applicant names beginning “Fukuda”

FDA records each applicant name separately; these may or may not be the same firm.

Fukuda Denshi Co., Ltd. 2