510(k) · Cleared
Cleared9131 Defibrillation Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science Corporation · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Dec 12, 2008 as substantially equivalent to K971149 (Survivalink Corp., 1997) after a 141-day review. Its family tree reaches back 2 generations to 1992. 1 of the 7 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Dec 12, 2008
- Review
- 141 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914955 (1992). 4 later devices descend from it, 3 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK914955 K-Defib/Pace ElectrodeKatecho, Inc. · 1992
- 1 generation backK971149 SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 1997 · Recalled
- This deviceK082090 9131 Defibrillation ElectrodesCardiac Science Corporation · 2008
- Descendant · cites it directly · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
- Descendant · cites it directly · 0 of its ownK142803 Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK131494 Heart SyncHeart Sync, Inc. · 2013
Class I recalls in this family
- K142803 Skintact, various other tradenamescites it directly · 2014
Most influential descendants
Showing 4 of 4 · See all- K122758Powerheart G5 AedCardiac Science Corporation · 2014 · cites it directly1descendant
- K143714Powerheart G5 AEDCardiac Science Corporation · 2015 · 2 generations on0descendants
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · cites it directly0descendants
- K131494Heart SyncHeart Sync, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914955 | K-Defib/Pace Electrode | Katecho, Inc. | 1992 | — |
| −1 | K971149 | SVL-9130 Defibrillation Electrode | Survivalink Corp. | 1997 | 1 |
| 0 (this device) | K082090 | 9131 Defibrillation Electrodes | Cardiac Science Corporation | 2008 | — |
| +1 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +2 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
| +1 | K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014 | Class I |
| +1 | K131494 | Heart Sync | Heart Sync, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 1 |
| 2015 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K971149 | SVL-9130 Defibrillation ElectrodeSummary page 1…: manufactured by Cardiac Science, Inc are substantially equivalent to the Survivalink-9130 Defibrillation Electrode, K971149, (6/23/1997) Device The model 9131 and the 9133 Defibrillation Electrodes Description: consists of a pair (… | 1997 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K122758 (Cardiac Science Corporation, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K971149.
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. 2008, this device’s year, is highlighted.
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?
Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to…
Read the full statement (151 words)
Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient.
Cardiac Science 9133 Defibrillation Electrodes are single use and intended to be used in conjunction with compatible automatic external defibrillators (AED) from Zoll or Physio-Control to monitor and deliver defibrillation energy to the patient, via brand-specific adapters. The brand-specific adapters are available for the AEDs specified in the product labeling.
The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.
The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082090: 9131 Defibrillation Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082090
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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