# K072950: Cygnus 12 Lead Ecg Module

- Pathway: 510(k) (Traditional)
- Applicant: Cygnus, LLC
- Decided: Aug 22, 2008 after 309 days
- Product code: KRE (Analyzer, Pacemaker Generator Function, Indirect)
- Device class: 2
- Regulation: 21 CFR 870.3640
- 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 K915632 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915632: Paceart CPTS-86/12, Paceart, Inc. (1992) Summary page 2.

## Indications for use
The device is for prescription use only. The device is intended to be used in a clinic or hospital. The device is intended for use by the physician (or his/her representative), not by the patient, although one intended use is to record the patient's 12-lead ECG. The device is intended for use as a: Fully functional ECG/heart rate monitoring system for clinical use. Pacemaker Detection and measurement. A TTM (trans-telephonic) Receiving Station. In TTM mode, the device is intended for use with landline analog and digital PBX telephone systems only. It is not intended to be used with wireless networks.

Source page: https://510kreport.com/device/K072950
Methodology: https://510kreport.com/methodology