# K032290: Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Oct 10, 2003 after 78 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: 3 generations back to K894628 (1990). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971131: Fukuda Denshi Model DS-5100E Portable Patient Monitor, Fukuda Denshi USA, Inc. (1997) Summary page 2.

## Most influential descendants
- K040246: Fukuda Denshi Dynascope Model DS-7141 Portable Patient Monitor (2004), 4 descendants of its own
- K081891: Fukuda Denshi Dynascope Model DS-7000/7000M Patient Monitor (2008), 3 descendants of its own
- 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 Model DS-7100 series Portable 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 and or invasive blood pressure, temperature and pulse oximetry. 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-7100 series is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7100 is also indicated where a hard copy record of the physiological parameters, the alarmed conditions or the trended values may be required.

Source page: https://510kreport.com/device/K032290
Methodology: https://510kreport.com/methodology