510(k) · Cleared
ClearedElectrode System, Quik-Prep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quinton, Inc. · DRX Electrode, Electrocardiograph
Cleared on Feb 1, 1979 after a 50-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 1, 1979
- Review
- 50 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK782079 Electrode System, Quik-PrepQuinton, Inc. · 1979
- Descendant · cites it directly · 2 of its ownK962115 Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK023713 Sonoprep Impedance Diagnostics (Idx) System, Model D1000Sontra Medical, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK013615 Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK090249 Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK040525 Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic…Sontra Medical, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K962115Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc. · 1996 · cites it directly2descendants
- K023713Sonoprep Impedance Diagnostics (Idx) System, Model D1000Sontra Medical, Inc. · 2004 · cites it directly1descendant
- K013615Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002 · 2 generations on1descendant
- K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009 · 3 generations on0descendants
- K040525Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000Sontra Medical, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K782079 | Electrode System, Quik-Prep | Quinton, Inc. | 1979 | — |
| +1 | K962115 | Cambridge Heart HI-Res Ecg Electrode | Cambridge Heart, Inc. | 1996 | — |
| +1 | K023713 | Sonoprep Impedance Diagnostics (Idx) System, Model D1000 | Sontra Medical, Inc. | 2004 | — |
| +2 | K013615 | Micro-Induction 1000 System | Harbinger Medical, Inc. | 2002 | — |
| +3 | K090249 | Modification to: Micro-Induction 1000 System | Harbinger Medical, Inc. | 2009 | — |
| +2 | K040525 | Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model… | Sontra Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2009 | 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 DRX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 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, K962115 (Cambridge Heart, Inc., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K782079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K782079: Electrode System, Quik-Prep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K782079
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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