# K131272: Siren Epcr Suite

- Pathway: 510(k) (Traditional)
- Applicant: Medusa Medical Technologies, Inc.
- Decided: Jan 3, 2014 after 245 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941811 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103473: Zoll Rescuenet Epcr Model Rescuenet Epcr, ZOLL Medical Corporation (2011) Summary page 5.

## Indications for use
Siren ePCR Suitem is intended for the collection, storage and printing of patient data that is entered by a user (paramedic), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). Siren ePCR Suite m is intended for use by qualified medical personnel providing direct patient care In the pre-hospital environment to document the care provided. Siren ePCR Suite'" is indicated for use by health care providers whenever there is a need for generation of a patient record.

Source page: https://510kreport.com/device/K131272
Methodology: https://510kreport.com/methodology