# K971131: Fukuda Denshi Model DS-5100E Portable Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: Oct 3, 1997 after 190 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 2 generations back to K894628 (1990). 2 ancestors in all.
6 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)
- K964187: Fukada Denshi Dynascope Model DS-5300 Patient Monitor, Fukuda Denshi USA, Inc. (1997). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K032290: Fukuda Denshi Dynascope Model DS-7100 Series Portable Patient Monitor (2003), 5 descendants of its own
- 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

## Indications for use
Use of the Fukuda Denshi model DS-5100E Portable Patient Monitor system is indicated in those clinical settings where Observations 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 pressures, temperature, and/or pulse oximetry. The observations may include an audible and visual alarm if any of these parameters exceed values that are establish by the clinician. The observations may also include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. An instantaneous display of waveforms, numeric, and trended values is desired. a hard copy record of the physiological parameters, the alarmed conditions, or the trended values may be required. where the patient may need to be monitored while being transported within the healthcare facility.

Source page: https://510kreport.com/device/K971131
Methodology: https://510kreport.com/methodology