# K883152: EP-Stat

- Pathway: 510(k) (Traditional)
- Applicant: Coherent Systems, Inc.
- Decided: Oct 13, 1988 after 79 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031000: Labsystem Iii EP Laboratory W/Windows Platform & Windows EP Software Version 1.0 (2003), 14 descendants of its own
- K101331: Labsystem Pro EP Recording System V3.1 Software (2010), 13 descendants of its own
- K113811: V2.6 Software for the Labsystem Pro EP Recording System (2012), 12 descendants of its own
- K140497: Ecvue Mapping System (2014), 8 descendants of its own
- K150990: ECVUE Mapping System (2015), 7 descendants of its own

Source page: https://510kreport.com/device/K883152
Methodology: https://510kreport.com/methodology