# K092010: PC Ecg, Model SE-1010

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Oct 22, 2009 after 108 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: 5 generations back to K903644 (1991). 8 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031561: Cardiosoft/Case Cardiac Testing System, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Most influential descendants
- K102854: PC ECG (2010), 13 descendants of its own
- K131819: PC ECG (2013), 12 descendants of its own
- K152427: PC ECG (2016), 11 descendants of its own
- K093869: SE-601 Series Electrocardiograph (2010), 10 descendants of its own
- K131503: SE-601 Series Electrocardiograph (2014), 9 descendants of its own

## Indications for use
SE-I010 PC ECG is intended to acquire ECG signals, from adult and pediatric patients through body surface ECG electrodes. SE-1010 PC ECG is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by SE-I010 PC ECG can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Source page: https://510kreport.com/device/K092010
Methodology: https://510kreport.com/methodology