# K093976: Raisin Personal  Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Proteus Biomedical, Inc.
- Decided: Mar 25, 2010 after 91 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963725 (1997). 13 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083174: Healthepod, Card Guard Scientific Survival, Ltd. (2009) Summary page 1.
- K052489: Actiheart, Respironics, Inc. (2005) Summary page 1.
- K991033: Actiwatch-Score, Mini-Mitter Co., Inc. (1999) Summary page 1.

## Most influential descendants
- K131009: Proteus Patch, Ingestible Sensor (Accessory) (2013), 6 descendants of its own
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory) (2014), 4 descendants of its own
- K110015: Vitalsens, Aingeal, V-Pod (2011), 4 descendants of its own
- K150494: Proteus Digital Health Feedback Device (2015), 3 descendants of its own
- K223463: Otsuka Digital Feedback Device-RW (2023), 1 descendant of its own

## Indications for use
The Raisin TM Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relatively to gravity, and time-stamped, patient-logged events. The Raisin TM PersonalMonitor enables unattended data collection for clinical and research applications. The RaisinTM PersonalMonitor may be used in any instance where quantifiable analysis of event-associated heart rate, activity, and body position is desirable.

Source page: https://510kreport.com/device/K093976
Methodology: https://510kreport.com/methodology