510(k) · Cleared
ClearedPrucka Engineering Inc. Cardiolab EP System,Version 4.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prucka Engineering, Inc. · DPS Electrocardiograph
Cleared on Apr 7, 2000 as substantially equivalent to K971570 (Quinton Electrophysiology Corp., 1997) and 2 other predicates after a 178-day review. Its family tree reaches back 2 generations to 1986. 18 later devices descend from it.
- Decided
- Apr 7, 2000
- Review
- 178 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K862740 (1986). 6 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK862740 Quinton Q.CathQuinton, Inc. · 1986
- 1 generation backK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- This deviceK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK020440 NewcorSiemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · cites it directly · 7 of its ownK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- Descendant · 2 generations on · 5 of its ownK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK161245 EP-TRACER SystemCardio Tek, BV · 2016 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K020440NewcorSiemens Medical Systems, Inc. · 2002 · cites it directly9descendants
- K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007 · cites it directly7descendants
- K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · 2 generations on5descendants
- K101571Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · 2 generations on5descendants
- K161245EP-TRACER SystemCardio Tek, BV · 2016 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K862740 | Quinton Q.Cath | Quinton, Inc. | 1986 | — |
| −1 | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| 0 (this device) | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| +1 | K020440 | Newcor | Siemens Medical Systems, Inc. | 2002 | 10 |
| +1 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| +2 | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | 1 |
| +2 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
| +3 | K161245 | EP-TRACER System | Cardio Tek, BV | 2016 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K971570 | Epxpress System (Timberwolf Revision) /000391Summary page 1…fier and Signal Conditioner Programmable Diagnostic Computer Blood Pressure Computer C. Substantial equivalence is claimed to the following devices: Quinton EP System (K971570) EP Medsystem EP System (K935186) Biosense Carto System (K954395) D. Description of device: The CardioLab EP System is a microp… | 1997 |
| * | K935186 | Electrophysiology Systems, Inc. EP-EasySummary page 1…ammable Diagnostic Computer Blood Pressure Computer C. Substantial equivalence is claimed to the following devices: Quinton EP System (K971570) EP Medsystem EP System (K935186) Biosense Carto System (K954395) D. Description of device: The CardioLab EP System is a microprocessor based data acquisition s… | 1995 |
| * | K954395 | Carto SystemSummary page 1…d Pressure Computer C. Substantial equivalence is claimed to the following devices: Quinton EP System (K971570) EP Medsystem EP System (K935186) Biosense Carto System (K954395) D. Description of device: The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiol… | 1995 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K020440 (Siemens Medical Systems, Inc., 2002) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and…
Read the full statement (174 words)
The intended use of the Prucka Engineering, Inc. CardioLab EP 4.2 System is to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators.
The CardioLab EP system does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during an EP procedure. It does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.
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/K993414 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993414: Prucka Engineering Inc. Cardiolab EP System,Version 4.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993414
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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