510(k) · Cleared
ClearedEpxpress System (Timberwolf Revision) /000391
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton Electrophysiology Corp. · DRR Amplifier And Signal Conditioner, Biopotential
Cleared on Dec 29, 1997 as substantially equivalent to K902716 (Prucka Engineering, Inc., 1990) and 2 other predicates after a 244-day review. Its family tree reaches back 1 generation to 1986. 19 later devices descend from it.
- Decided
- Dec 29, 1997
- Review
- 244 days
- Class
- Class II
- Product code
- DRR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K862740 (1986). 3 ancestors in all. 19 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK862740 Quinton Q.CathQuinton, Inc. · 1986
- This deviceK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- Descendant · cites it directly · 18 of its ownK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- Descendant · 2 generations on · 9 of its ownK020440 NewcorSiemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 7 of its ownK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- Descendant · 3 generations on · 5 of its ownK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
- Descendant · 3 generations on · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K993414Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000 · cites it directly18descendants
- K020440NewcorSiemens Medical Systems, Inc. · 2002 · 2 generations on9descendants
- K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007 · 2 generations on7descendants
- K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · 3 generations on5descendants
- K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862740 | Quinton Q.Cath | Quinton, Inc. | 1986 | — |
| 0 (this device) | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| +1 | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| +2 | K020440 | Newcor | Siemens Medical Systems, Inc. | 2002 | 10 |
| +2 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| +3 | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | 1 |
| +3 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902716 | PE Electrophysiology Lab System (Peep)Summary page 1…quivalence is the PE Electrophysiology Lab System and CardioLab Amplifier Module both manufactured by Prucka Engineering, Inc. . The 510(k) numbers for these devices are K902716 and K910307, respectively. Additionally, we claim equivalence to the Quinton Q-Cath System manufactured by Quinton Instrument Com… | 1990 |
| * | K910307 | Cardiolab Amplifier Module (Cam)Summary page 1…s the PE Electrophysiology Lab System and CardioLab Amplifier Module both manufactured by Prucka Engineering, Inc. . The 510(k) numbers for these devices are K902716 and K910307, respectively. Additionally, we claim equivalence to the Quinton Q-Cath System manufactured by Quinton Instrument Company. The 51… | 1991 |
| * | K862740 | Quinton Q.CathSummary page 1…d K910307, respectively. Additionally, we claim equivalence to the Quinton Q-Cath System manufactured by Quinton Instrument Company. The 510(k) number for this device is K862740. C. Device Description The EPXpress System (Timberwolf Revision) is an integrated catheter switching amplificati… | 1986 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | 2000 | 18 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DRR devicesDRR Amplifier And Signal Conditioner, Biopotential: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRR
FDA has decided no DRR device since 2007.
Median 510(k) review, days · DRR
Too few DRR 510(k)s in any year since 2007 to give a median.
Recalls per year · DRR
No recall names DRR since 2007.
Adverse event reports per year · DRR
1in 2008
MAUDE reports naming product code DRR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (102 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971570 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971570: Epxpress System (Timberwolf Revision) /000391.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971570
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026