# K102111: Medical Magnetic Tape Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Wpr Medical AS
- Decided: Dec 7, 2010 after 132 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: 7 generations back to K882803 (1988). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042108: Vista Plus, Novacor (2005) Summary page 1.
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System, Corventis, Inc. (2009) Summary page 1.

## Indications for use
Curvus Sensor - Recorder: Curvus Regular Hlter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer. The Sensor and Recorder are intended for use outside of the hospital. Curvus software suite: Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyzes the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.

Source page: https://510kreport.com/device/K102111
Methodology: https://510kreport.com/methodology