# K050686: Cardiovit at-10PLUS

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: May 4, 2005 after 49 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953396 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031557: Cardiovit at-102, Schiller AG (2004) Summary page 1.

## Most influential descendants
- K152043: Diagnostic Station DS20 (2016), 1 descendant of its own
- K170182: Cardiovit FT-1 (2017), 0 descendants of its own

## Indications for use
The AT-1 oPlus is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-10Plus can be used as a diagnostic aid for heart function and heart conditions. The AT-10Plus is designed for indoor use. The device provide an optional interface to the SP-250 for pulmonary function data.

Source page: https://510kreport.com/device/K050686
Methodology: https://510kreport.com/methodology