# K031557: Cardiovit at-102

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Apr 14, 2004 after 331 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: 1 generation back to K953396 (1995). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953396: Cardiovit at-1C, at-2C, Schiller America, Inc. (1995) Summary page 1.

## Most influential descendants
- K053207: Argus, Model LCM (2006), 5 descendants of its own
- K101619: Welch Allyn 1500 Patient Monitor (2010), 4 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K050686: Cardiovit at-10PLUS (2005), 2 descendants of its own

## Indications for use
The AT-102 is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. The AT-102 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/K031557
Methodology: https://510kreport.com/methodology