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FUKUDA DENSHI USA, INC.

Last updated September 17, 2026

Information

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Hl-300 Receiver Module	K915879	FDA 510(k)	Class II	Active
Fukuda Denshi Model Spirosift Sp-5000	K922428	FDA 510(k)	Class II	Active
Fukuda Denshi Eh-11	K834059	FDA 510(k)	Class II	Active
Fukuda Model Ds-503 Dynascope Patient Monitor	K875057	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-7141 Portable Patient Monitor	K040246	FDA 510(k)	Class II	Active
Fukuda Denshi Model Ds-3300 Etr	K897063	FDA 510(k)	Class II	Active
Ecg Monitor	K944262	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-5000 Central Telemetry System	K033711	FDA 510(k)	Class II	Active
Fukuda Denshi Model Uf-850xtd	K050363	FDA 510(k)	Class II	Active
Fukuda Denshi Model Hc-300 End Tidal Co2 Module	K950044	FDA 510(k)	Class II	Active
Model U-1000 Ultrasonic Scanner	K851902	FDA 510(k)	Class II	Active
Fukuda Denshi Model Hg-301	K921454	FDA 510(k)	Class II	Active
Fukuda Denshi Model Ff Sonic Uf-750xt	K033209	FDA 510(k)	Class II	Active
Fukuda Denshi Ultrasound Scanners Models Uf-3500 And Uf-4500	K981404	FDA 510(k)	Class II	Active
Fukuda Denshi Dynascope Model Ds-5800 Central Station Monitor	K970585	FDA 510(k)	Class II	Active
Fukuda Denshi Model Fx-1201	K884992	FDA 510(k)	Class II	Active
Scm-400 Holter System	K860950	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 21, 2015	Z-0661-2016	—	terminated	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).