510(k) · Cleared
ClearedPE Electrophysiology Lab System (Peep)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prucka Engineering, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 4, 1990 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Sep 4, 1990
- Review
- 76 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 2 citing it directly.
- This deviceK902716 PE Electrophysiology Lab System (Peep)Prucka Engineering, Inc. · 1990
- Descendant · cites it directly · 19 of its ownK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- Descendant · 2 generations on · 18 of its ownK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- Descendant · 3 generations on · 9 of its ownK020440 NewcorSiemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 7 of its ownK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- Descendant · 4 generations on · 5 of its ownK134044 EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K971570Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997 · cites it directly19descendants
- K993414Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000 · 2 generations on18descendants
- K020440NewcorSiemens Medical Systems, Inc. · 2002 · 3 generations on9descendants
- K071348Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007 · 3 generations on7descendants
- K134044EP-Tracer System, EP-Tracer System, EP-Tracer SystemCardio Tek, BV · 2014 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902716 | PE Electrophysiology Lab System (Peep) | Prucka Engineering, Inc. | 1990 | — |
| +1 | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| +2 | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| +3 | K020440 | Newcor | Siemens Medical Systems, Inc. | 2002 | 10 |
| +3 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| +4 | K134044 | EP-Tracer System, EP-Tracer System, EP-Tracer System | Cardio Tek, BV | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 212 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?
- Of its descendants, K971570 (Quinton Electrophysiology Corp., 1997) has gone furthest, with 19 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
https://510kreport.com/device/K902716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902716: PE Electrophysiology Lab System (Peep).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902716
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026