510(k) · Cleared
ClearedPure EP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosig Technologies · DQK Computer, Diagnostic, Programmable
Cleared on Aug 8, 2018 as substantially equivalent to K130626 (Ge Medical Systems Information Technologies, Inc., 2013) after a 133-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Aug 8, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001305 (2000). No later device cites it as a predicate yet.
- Root · 7 generations backK001305 Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn · 2000
- 6 generations backK021366 Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 5 generations backK032577 Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003
- 4 generations backK050093 Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 3 generations backK061741 Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006
- 2 generations backK111200 Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare · 2011
- 1 generation backK130626 Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology…Ge Medical Systems Information Technologies, Inc. · 2013 · Recalled
- This deviceK180805 Pure EPBiosig Technologies · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001305 | Mac-Lab System and Cardiolab EP System | General Electric Medical Systems Information Techn | 2000 | — |
| −6 | K021366 | Mac-Lab/Cardiolab EP/Combolab | General Electric Medical Systems Information Techn | 2002 | 1 |
| −5 | K032577 | Modification to: Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2003 | — |
| −4 | K050093 | Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2005 | 4 |
| −3 | K061741 | Mac-Lab/Cardiolab /Combolab/Specialslab System | GE Healthcare | 2006 | — |
| −2 | K111200 | Mac-Lab System, Cardiolab System, Combolab System, Specialslab System | GE Healthcare | 2011 | — |
| −1 | K130626 | Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording… | Ge Medical Systems Information Technologies, Inc. | 2013 | 1 |
| 0 (this device) | K180805 | Pure EP | Biosig Technologies | 2018 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K130626 | Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Summary page 4…Class II, per 21 CFR 870.1425 Product Code: DQK Predicate Device(s): The subject device is equivalent to the following devices: K130626 GE Healthcare; CardioLab (other systems included in cleared 510(k) application) Device Description:… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130626.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 | — |
What is it indicated for?
PURE EP™ is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180805: Pure EP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180805
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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