510(k) · Cleared
ClearedHeartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation Pads with Preattached Electrode Adapter (DP-Eaxx)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartstream, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 25, 1997 after a 90-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 25, 1997
- Review
- 90 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972418 Heartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation…Heartstream, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK033144 Defibtech Electrode Adapter, Model Dac-300 SeriesDefibtech, LLC · 2003
Most influential descendants
Showing 1 of 1 · See all- K033144Defibtech Electrode Adapter, Model Dac-300 SeriesDefibtech, LLC · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972418 | Heartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation Pads with… | Heartstream, Inc. | 1997 | — |
| +1 | K033144 | Defibtech Electrode Adapter, Model Dac-300 Series | Defibtech, LLC | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 MKJ? 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? (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 |
|---|---|---|---|
| * | — | Heartstream External Defibrillation Pads Named without a submission number | |
| * | — | K-Defib/Pace Multifunction Electrodes Named without a submission number | |
| * | — | Darox R2 series of adapter cables Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033144 | Defibtech Electrode Adapter, Model Dac-300 Series | 2003 | 0 |
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, K033144 (Defibtech, LLC, 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
Heartstream Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
Heartstream External Defibrillation Pads with Preattached Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
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/K972418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972418: Heartstramelectrode Adapter (EA-XX Series)/Heartstram Defibrillation Pads with Preattached Electrode Adapter (DP-Eaxx).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972418
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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