# K964187: Fukada Denshi Dynascope Model DS-5300 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Fukuda Denshi USA, Inc.
- Decided: May 1, 1997 after 192 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: 1 generation back to K894628 (1990). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894628: Model DS-3300 Dynascope Patient Monitor, Fukuda Denshi USA, Inc. (1990) Summary page 1.

## Most influential descendants
- K971131: Fukuda Denshi Model DS-5100E Portable Patient Monitor (1997), 6 descendants of its own
- 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

## Indications for use
The Fukuda Denshi model DS-5300 Patient Monitor provides a simple and reliable method to display and document the continuos hemodynamic, cardiovascular observations that are typically required of critically ill patients. These patients; neonate, pediatric, and adult; may be located in a hospital ICU, CCU, OR, ER, recovery, or other critical care unit. The DS-5300 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. Parameters such as ECG, respiration, non-invasive or invasive blood pressures, temperature, pulse oximetry, and cardiac output may be monitored individually or in any grouping required by the clinician. This device is not intended for home use.

Source page: https://510kreport.com/device/K964187
Methodology: https://510kreport.com/methodology