510(k) · Cleared
ClearedSmart Bilectrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electronics For Medicine, Inc. · DRX Electrode, Electrocardiograph
Cleared on Jun 11, 1979 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 11, 1979
- Review
- 11 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK791006 Smart BilectrodesElectronics For Medicine, Inc. · 1979
- Descendant · cites it directly · 2 of its ownK962115 Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc. · 1996
- 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
Most influential descendants
Showing 3 of 3 · See all- K962115Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc. · 1996 · cites it directly2descendants
- K013615Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002 · 2 generations on1descendant
- K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791006 | Smart Bilectrodes | Electronics For Medicine, Inc. | 1979 | — |
| +1 | K962115 | Cambridge Heart HI-Res Ecg Electrode | Cambridge Heart, Inc. | 1996 | — |
| +2 | K013615 | Micro-Induction 1000 System | Harbinger Medical, Inc. | 2002 | — |
| +3 | K090249 | Modification to: Micro-Induction 1000 System | Harbinger Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962115 | Cambridge Heart HI-Res Ecg Electrode | 1996 | 2 |
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/K791006 · printed Nov 4, 2026
Cite this page
510(k) Report. “K791006: Smart Bilectrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K791006
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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