# K081891: Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Aug 29, 2008 after 58 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: 6 generations back to K962603 (1997). 24 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have 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 2.
- K040246: Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor, Fukuda Denshi USA, Inc. (2004) Summary page 2.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 2.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 2.
- K012059: 8100/8500 Vital Signs Monitor, Criticare Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K083697: Fukuda Denshi Dynascope Model DS-7000 Series Patient Monitor, Model DS-7000//7000M/7210/7210M (2009), 2 descendants of its own
- K150030: Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor (2015), 0 descendants of its own
- K134046: Fukuda Denshi Dynascope Model DS-8100N/8100M Patient Monitor (2015), 0 descendants of its own

## Indications for use
Use of the Fukuda Denshi DynaScope Model DS-7000/7000M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NJBP), pulse rate, arterial oxygen saturation (SpO 2 ), pulse wave, temperature, invasive blood pressure (IBP), cardiac output, carbon dioxide concentration (CO 2), nitrous oxide concentration (N 2 0), oxygen concentration (02), and anesthetic agent concentration (AG). The target populations of the system are adult, pediatric, and neonatal patients with the exception of the ST segment and arrhythmia analysis, for which the target populations are adult and pediatric only. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7000/7000M is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7000/7000M also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

Source page: https://510kreport.com/device/K081891
Methodology: https://510kreport.com/methodology