Fukuda Denshi USA, Inc.
Redmond, WA, US
FUKUDA DENSHI USA, INC. appears in FDA device records in Redmond, WA. FDA records list 68 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Fukuda Denshi USA, Inc. between 1984 and 2018. The busiest year on record is 1985, with 8. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 4 |
| 1985 | 8 |
| 1986 | 3 |
| 1987 | 4 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 7 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 6 |
| 1998 | 4 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 2 |
| 2015 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K173226 | CardiMax Electrocardiograph | DPS | Substantially Equivalent | |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | MHX | Substantially Equivalent | |
| K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR | MHX | Substantially Equivalent | |
| K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 | DXN | Substantially Equivalent | |
| K103134 | FUKUDA DENSHI | MHX | Substantially Equivalent | |
| K083697 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M | MHX | Substantially Equivalent | |
| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | IYN | Substantially Equivalent | |
| K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | MHX | Substantially Equivalent | |
| K050363 | FUKUDA DENSHI MODEL UF-850XTD | IYN | Substantially Equivalent | |
| K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM | MHX | Substantially Equivalent | |
| K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR | MHX | Substantially Equivalent | |
| K033209 | FUKUDA DENSHI MODEL FF SONIC UF-750XT | IYN | Substantially Equivalent | |
| K032290 | FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR | MHX | Substantially Equivalent | |
| K020084 | FUKUDA DENSHI DYNASCOPE MODEL DS-5700 | DSI | Substantially Equivalent | |
| K013273 | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE | DQA | Substantially Equivalent | |
| K000746 | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX | DSI | Substantially Equivalent | |
| K990401 | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER | IYO | Substantially Equivalent | |
| K981066 | FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K980728 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM | DSI | Substantially Equivalent | |
| K980979 | FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE | CCK | Substantially Equivalent | |
| K981404 | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 | IYO | Substantially Equivalent | |
| K971440 | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH | LOS | Substantially Equivalent | |
| K971131 | FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR | DSI | Substantially Equivalent | |
| K970585 | FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR | DSI | Substantially Equivalent | |
| K964187 | FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR | DSI | Substantially Equivalent | |
| K963057 | FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER | DSI | Substantially Equivalent | |
| K955543 | ULTRASOUND SYSTEM MODEL UF-3500 | IYO | Substantially Equivalent | |
| K955416 | CARDIMAX MODEL FX-2111 | DPS | Substantially Equivalent | |
| K950044 | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE | CCK | Substantially Equivalent | |
| K944262 | ECG MONITOR | DRT | Substantially Equivalent | |
| K945464 | FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE | DQA | Substantially Equivalent | |
| K921454 | FUKUDA DENSHI MODEL HG-301 | DQA | Substantially Equivalent | |
| K922208 | FUKUDA DENSHI MODEL UF-4500 | IYO | Substantially Equivalent | |
| K922428 | FUKUDA DENSHI MODEL SPIROSIFT SP-5000 | BZG | Substantially Equivalent | |
| K915879 | HL-300 RECEIVER MODULE | DPS | Substantially Equivalent | |
| K913811 | FUKUDA DENSHI MODEL FCP-4101 | LOS | Substantially Equivalent | |
| K904200 | SPIROSIFT 500A | BZG | Substantially Equivalent | |
| K903514 | FUKUDA DENSHI MODEL LX-3100 | DSI | Substantially Equivalent | |
| K903704 | FUKUDA DENSHI MODEL FCP-2201 MODIFICATION | DSI | Substantially Equivalent | |
| K901817 | FUKUDA DENSHI MODEL FX-3101 | DPS | Substantially Equivalent | |
| K901889 | FUKUDA DENSHI MODEL HJ-310 | DXN | Substantially Equivalent | |
| K900391 | FUKUDA DENSHI MODEL SPIROSIFT 3000 | BZG | Substantially Equivalent | |
| K897063 | FUKUDA DENSHI MODEL DS-3300 ETR | DSI | Substantially Equivalent | |
| K897094 | MODIFIED SPIROSCAN 1000 | BZG | Substantially Equivalent | |
| K894628 | MODEL DS-3300 DYNASCOPE PATIENT MONITOR | DSI | Substantially Equivalent | |
| K893405 | MODEL DS-504 DYNASCOPE PATIENT MONITOR | DRT | Substantially Equivalent | |
| K892796 | FUKUDA DENSHI MODEL FCP-2201 | LOS | Substantially Equivalent | |
| K884992 | FUKUDA DENSHI MODEL FX-1201 | DPS | Substantially Equivalent | |
| K875057 | FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR | DPS | Substantially Equivalent | |
| K874768 | FUKUDA DENSHI MODEL FCP-231 | DSI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3031158 | 3000215024 | FUKUDA DENSHI USA, INC. | 17725 N.E. 65TH ST., BLDG. C, REDMOND, WA 98052 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DSKComputer, Blood-Pressure
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- FFLDislodger, Stone, Basket, Ureteral, Metal
- DPSElectrocardiograph
- HEMImager, Ultrasonic Obstetric-Gynecologic
- OUGMedical Device Data System
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DQCPhonocardiograph
- DSFRecorder, Paper Chart
- BZGSpirometer, Diagnostic
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- JOOTransducer, Heart Sound
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0661-2016 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients. | A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery). | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain