# Fukuda Denshi USA, Inc.

- Location (FDA's records): Redmond, WA
- FDA decisions: 68 (1984–2018): 68 510(k) clearances
- Product codes: DSI (19), MHX (8), DPS (7), BZG (4), IYO (4), DRT (4), LOS (4), IYN (3), DQA (3), DXN (3), CCK (2), DSF (2)
- Predicates its devices cite: 48 (30 its own); citations of its devices by later devices: 31 (30 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Nihon Kohden America, Inc.: 2 (https://510kreport.com/company/nihon-kohden-america)
- Hitachi Medical Corp.: 1 (https://510kreport.com/company/hitachi-medical)
- Datascope Corp.: 1 (https://510kreport.com/company/datascope)
- Oridion Capnography, Inc.: 1 (https://510kreport.com/company/oridion-capnography)
- Respironics Novametrix, Inc.: 1 (https://510kreport.com/company/respironics-novametrix)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)

## Firms that cite its devices most
- Alliance Medical Corp.: 1 (https://510kreport.com/company/alliance-medical)

## Its most-cited devices
- K964187: Fukada Denshi Dynascope Model DS-5300 Patient Monitor (1997), cited by 4
- K922208: Fukuda Denshi Model UF-4500 (1993), cited by 3
- K083697: Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M (2009), cited by 2
- K894628: Model DS-3300 Dynascope Patient Monitor (1990), cited by 2
- K981066: Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph (1998), cited by 2
- K033209: Fukuda Denshi Model FF Sonic UF-750XT (2003), cited by 2

## Recent decisions
- K173226: CardiMax Electrocardiograph (Apr 16, 2018)
- K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (Mar 16, 2015)
- K134046: Fukuda Denshi Dynascope Model DS-8100N/8100M Patient Monitor (Feb 12, 2015)
- K112521: Fukuda Denshi Vasera Model VS-1500 (Dec 21, 2011)
- K103134: Fukuda Denshi (Mar 11, 2011)
- K083697: Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M (Mar 19, 2009)
- K082656: Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit (Sep 30, 2008)
- K081891: Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor (Aug 29, 2008)

Source page: https://510kreport.com/company/fukuda-denshi-usa