Fukuda Denshi USA, Inc.: FDA filings under this applicant name
FDA lists 68 510(k) clearances under the applicant name “Fukuda Denshi USA, Inc.” (first 1984, latest 2018), across 17 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 238 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 195 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fukuda Denshi USA, Inc. took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 19 | 19 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 8 | 8 |
| DPS | Electrocardiograph | 7 | 7 |
| BZG | Spirometer, Diagnostic | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| LOS | 4 | 4 | |
| DQA | Oximeter | 3 | 3 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
Plus 7 more product codes.
Review panels
- Cardiovascular (45)
- Anesthesiology (9)
- Radiology (7)
- Obstetrics and Gynecology (2)
Most recent Fukuda Denshi USA, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173226 | CardiMax Electrocardiograph | DPS | 2018-04-16 | 195 |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | MHX | 2015-03-16 | 67 |
| K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR | MHX | 2015-02-12 | 408 |
| K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 | DXN | 2011-12-21 | 112 |
| K103134 | FUKUDA DENSHI | MHX | 2011-03-11 | 137 |
| K083697 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M | MHX | 2009-03-19 | 94 |
| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | IYN | 2008-09-30 | 18 |
| K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | MHX | 2008-08-29 | 58 |
| K050363 | FUKUDA DENSHI MODEL UF-850XTD | IYN | 2005-02-17 | 3 |
| K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM | MHX | 2004-06-03 | 190 |
58 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-12-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Fukuda Denshi Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fukuda Denshi USA, Inc.?
FDA lists 68 510(k) clearances under the applicant name “Fukuda Denshi USA, Inc.” (first 1984, latest 2018), across 17 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fukuda Denshi USA, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fukuda Denshi USA, Inc. is 108 days.
Which FDA product codes appear under Fukuda Denshi USA, Inc.?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 19); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 8); DPS (Electrocardiograph, 7).
Next steps
- See all 68 Fukuda Denshi USA, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Fukuda Denshi USA, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.