# K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Mar 16, 2015 after 67 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 150 ancestors in all.
No later device cites it as a predicate yet.
1 of 151 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964187: Fukada Denshi Dynascope Model DS-5300 Patient Monitor, Fukuda Denshi USA, Inc. (1997) Summary page 5.
- K083697: Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M, Fukuda Denshi USA, Inc. (2009) Summary page 5.
- K062754: Gas Module SE, Model 0998-00-0481-02, Datascope Corp. (2006) Summary page 5.
- K981066: Fukuda Denshi: Cardiomax, Model FX-4010 Multi Channel Electrocardiograph, Fukuda Denshi USA, Inc. (1998) Summary page 5.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 5.
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 5.
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 5.
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 5.
- K053234: PM-9000 Express Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 5.

## Indications for use
The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor provides a simple and reliable method to display and document the continuous hemodynamic, cardiovascular observations that are typically required of critically ill patients. The target populations of the system are adult, pediatric, and neonatal patients, who may be located in a hospitals ICU, CCU, OR, ER, recovery or other critical care area, with the exception of the ST segment, arrhythmia analysis, and SpHb for which the target populations are adult and pediatric only excluding neonates. The DS-8000 Series monitor can also be used to follow patients whose treatment requires close observation of specific physiological parameters. These patients may be in a clinic or other healthcare environment under the care of a physician. The availability of DS-LAN connection, through either a built in Ethernet LAN or external telemetry transmitter, allows remote monitoring when combined with Fukuda Denshi Central Station Monitors. Parameters such as ECG, heart rate, respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO3), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), and total hemoglobin concentration (SpHb), plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (COy), nitrous oxide concentration (N20), oxygen concentration (O;), anesthetic agent concentration (AG), and Spirometry may be monitored individually or in any grouping required by the clinician. The Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor is not recommended for home use, when it has not been ordered by a physician.

Source page: https://510kreport.com/device/K150030
Methodology: https://510kreport.com/methodology