# K971570: Epxpress System (Timberwolf Revision) /000391

- Pathway: 510(k) (Traditional)
- Applicant: Quinton Electrophysiology Corp.
- Decided: Dec 29, 1997 after 244 days
- Product code: DRR (Amplifier And Signal Conditioner, Biopotential)
- Device class: 2
- Regulation: 21 CFR 870.2050
- 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 K862740 (1986). 3 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902716: PE Electrophysiology Lab System (Peep), Prucka Engineering, Inc. (1990) Summary page 1.
- K910307: Cardiolab Amplifier Module (Cam), Prucka Engineering, Inc. (1991) Summary page 1.
- K862740: Quinton Q.Cath, Quinton, Inc. (1986) Summary page 1.

## Most influential descendants
- K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2 (2000), 18 descendants of its own
- K020440: Newcor (2002), 9 descendants of its own
- K071348: Ems-XL Cardiac Electrophysiology System (2007), 7 descendants of its own
- K134044: EP-Tracer System, EP-Tracer System, EP-Tracer System (2014), 5 descendants of its own
- K101571: Xper Information Management and Flex Cardio Physiomonitoring Systems (2010), 5 descendants of its own

## Indications for use
The intended use of the Quinton Electrophysiology Corporation’s EPXpress System (Timberwolf Revision) is the acquisition, amplification, display, recording, and transmission of electrical signals of biological origin obtained during electrophysiology studies and related procedures. Such signals include ECG, intracardiac ECG, and blood pressure. Physiological parameters as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from these signals and displayed numerically, recorded, and/or transmitted. Additionally, the EPXpress System (Timberwolf Revision) may acquire, transpose, amplify, display, record and transmit measurement data received from other medical devices typically used during these procedures, such as oximeters, RF generators, or electronic thermometers.

Source page: https://510kreport.com/device/K971570
Methodology: https://510kreport.com/methodology