# K091505: COR12+

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Healthcare GmbH
- Decided: Jun 10, 2009 after 20 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- 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 K002074 (2000). 10 ancestors in all.
6 later devices descend from it; 1 cites it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050896: H12+ Holter Recorder, Mortara Instrument, Inc. (2005) Summary page 2.
- K082124: Carditte Microtel, Et Medical Devices Spa (2009) Summary page 2.
- K082539: Masterscope, Masterscope Ecg, Masterscope CT, Cardinal Health Germany 234 GmbH (2008) Summary page 2.

## Most influential descendants
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own
- K183567: Vyntus/SentrySuite Product Line (2019), 0 descendants of its own
- K190853: Vyntus BODY (2019), 0 descendants of its own
- K183369: COR12 Ecg (2018), 0 descendants of its own

## Indications for use
The Cor12+ Holter Recorder is intended to acquire, record and store ECG data of patients that have been connected to the Cor12+ recorder and are undergoing Holter monitoring. The Corl2+ acquires, digitizes and stores data to be analyzed on a computer with special software. The Cor12+ is indicated for use: in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 24 hours. The Corl2+ performs no cardiac analysis by itself; it solely records the ECG signals. The patient population for this device is from 4 years on and a minimum weight of 10 kg.

Source page: https://510kreport.com/device/K091505
Methodology: https://510kreport.com/methodology