510(k) · Cleared
ClearedFore Runner External Defibrillator/Defibrillator Pads
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 10, 1996 after a 274-day review. The FDA summary names its predicate without a number. 6 of the 49 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it.
- Decided
- Sep 10, 1996
- Review
- 274 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 7 citing it directly. 6 of the 49 devices in this family, counting this one, have a Class I recall.
- This deviceK955628 Fore Runner External Defibrillator/Defibrillator PadsHeartstream, Inc. · 1996
- Descendant · cites it directly · 25 of its ownK983393 Lifepak 500 BiphasicPhysio-Control Corp. · 1999 · Recalled
- Descendant · cites it directly · 22 of its ownK991910 Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · Recalled
- Descendant · 2 generations on · 21 of its ownK012274 Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · Recalled
- Descendant · 2 generations on · 21 of its ownK012428 Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001 · Recalled
- Descendant · 2 generations on · 20 of its ownK033275 Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 48 · See all- K983393Lifepak 500 BiphasicPhysio-Control Corp. · 1999 · cites it directly25descendants
- K991910Lifepak 12 BiphasicPhysio-Control Corp. · 1999 · cites it directly22descendants
- K012274Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/PacemakerMedtronic Physio-Control Corp. · 2002 · 2 generations on21descendants
- K012428Modification to: Lifepak 500 Automated External DefibrillatorMedtronic Physio-Control Corp. · 2001 · 2 generations on21descendants
- K033275Lifepak 12, 20, 500, CR PlusMedtronic Physio-Control Corp. · 2003 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955628 | Fore Runner External Defibrillator/Defibrillator Pads | Heartstream, Inc. | 1996 | — |
| +1 | K983393 | Lifepak 500 Biphasic | Physio-Control Corp. | 1999 | 1 |
| +1 | K991910 | Lifepak 12 Biphasic | Physio-Control Corp. | 1999 | 3 |
| +2 | K012274 | Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker | Medtronic Physio-Control Corp. | 2002 | 17 |
| +2 | K012428 | Modification to: Lifepak 500 Automated External Defibrillator | Medtronic Physio-Control Corp. | 2001 | 2 |
| +2 | K033275 | Lifepak 12, 20, 500, CR Plus | Medtronic Physio-Control Corp. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 1 |
| 2007 | 3 | 0 |
| 2008 | 5 | 1 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 1 |
| 2013 | 3 | 1 |
| 2014 | 5 | 2 |
| 2015 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
6 devices in this family have a Class I recall. 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? (10)
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 |
|---|---|---|---|
| * | — | Zoll Medical Corporation Semi-Automatic External Defibrillator Named without a submission number | |
| * | — | SurVivaLink Corporation Vivalink Semi-Automatic External Defibrillator Named without a submission number | |
| * | — | Laerdal Medical Corporation Heartstart Semi-automatic External Defibrillator Named without a submission number | |
| * | — | Hewlett Packard Corporation Codemaster XL Defibrillator/Monitor Named without a submission number | |
| * | — | PhysioControl Corporation LifePak 100 External Defibrillator Named without a submission number | |
| * | — | W. Kouwenhoven, M.D. Biphasic External Defibrillator (Johns Hopkins Hospital) Named without a submission number | |
| * | — | Mine Safety Appliance Company Biphasic External Defibrillator Named without a submission number | |
| * | — | Katecho, Inc. External Pacing and Defibrillation electrodes Named without a submission number | |
| * | — | Zoll Medical Corporation Multi-function electrodes Named without a submission number | |
| * | — | SurVivaLink Corporation Defibrillation electrodes Named without a submission number |
What descends from it? (48)
See all 487 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983393 | Lifepak 500 Biphasic | 1999 | 25 |
| K991910 | Lifepak 12 Biphasic | 1999 | 22 |
| K982264 | Firstsave Biphasic Models 9200 and 9210 | 1999 | 9 |
| K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)… | 2002 | 6 |
| K041883 | Skintact Multifunction Electrodes, Model DF 21 | 2004 | 4 |
| K120350 | Extended Life Battery | 2012 | 0 |
| K091548 | Amco Replacement Battery for Philips Medical Models BT1 and M5070A | 2009 | 0 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K130454Lifepak 20 Defibrillator/Monitor, Lifepak 20E Defibrillator/MonitorPhysio-Control, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K122600Lifepak 1000 DefibrillatorPhysio-Control, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K052465Reduced Energy Pediatric Electrode Pads for the Samaritan Aed and Pad, Models Sde 251, SPP 351Heartsine Technologies, Inc. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- Of its descendants, K983393 (Physio-Control Corp., 1999) has gone furthest, with 25 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?
The ForeRunner external defibrillator, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by unconsciousness, absence of breathing and absence of detectable pulse.
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/K955628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955628: Fore Runner External Defibrillator/Defibrillator Pads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955628
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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