510(k) · Cleared
Recalled · 2008SVL-9130 Defibrillation Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Survivalink Corp. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Jun 23, 1997 as substantially equivalent to K914955 (Katecho, Inc., 1992) after an 87-day review. Its family tree reaches back 1 generation to 1992. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 1997
- Review
- 87 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K914955 (1992). 6 later devices descend from it, 2 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK914955 K-Defib/Pace ElectrodeKatecho, Inc. · 1992
- This deviceK971149 SVL-9130 Defibrillation ElectrodeSurvivalink Corp. · 1997
- Descendant · cites it directly · 4 of its ownK082090 9131 Defibrillation ElectrodesCardiac Science Corporation · 2008
- Descendant · 2 generations on · 1 of its ownK122758 Powerheart G5 AedCardiac Science Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK143714 Powerheart G5 AEDCardiac Science Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK142803 Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK131494 Heart SyncHeart Sync, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K142803 Skintact, various other tradenames2 generations on · 2014
Most influential descendants
Showing 5 of 6 · See all- K0820909131 Defibrillation ElectrodesCardiac Science Corporation · 2008 · cites it directly4descendants
- K122758Powerheart G5 AedCardiac Science Corporation · 2014 · 2 generations on1descendant
- K143714Powerheart G5 AEDCardiac Science Corporation · 2015 · 3 generations on0descendants
- K142803Skintact, various other tradenamesLeonhard Lang GmbH · 2014 · 2 generations on0descendants
- K131494Heart SyncHeart Sync, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914955 | K-Defib/Pace Electrode | Katecho, Inc. | 1992 | — |
| 0 (this device) | K971149 | SVL-9130 Defibrillation Electrode | Survivalink Corp. | 1997 | — |
| +1 | K082090 | 9131 Defibrillation Electrodes | Cardiac Science Corporation | 2008 | — |
| +2 | K122758 | Powerheart G5 Aed | Cardiac Science Corporation | 2014 | — |
| +3 | K143714 | Powerheart G5 AED | Cardiac Science Corporation | 2015 | — |
| +2 | K142803 | Skintact, various other tradenames | Leonhard Lang GmbH | 2014 | Class I |
| +2 | K131494 | Heart Sync | Heart Sync, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K940455 | FDA’s K940455 is Lateral Flexion Machine Our OCR of the scanned summary read K940455, FDA’s number for Lateral Flexion Machine (Rehab, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SVL-9010 electrodes”. Kept off the family tree. Summary page 3…her legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the SVL-9130 electrode is substantially equivalent to SVL- 9010 electrodes (K940455) and Katecho’s D-Defib/Pace electrodes (K 914955). H-6. PERFORMANCE DATA The SVL-9130 electrodes meet all the spemficatlons for… | 1995 |
| * | K914955 | K-Defib/Pace ElectrodeSummary page 2…EDICATE DEVICE 1. SurVivaLink Model 9010 (9010) electrodes manufactured for SurVivaLink Corporation by Katecho Inc.models (K940445) 2. Katecho K-Defib/Pace electrodes (K914955) H-3. INDICATION FOR USE The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic exte… | 1992 |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2008 | Not classified | Z-1616-2008 | Process control | Adaptor Cable Incorrectly Manufactured: The red and white connector ends of the adapter are switched. Therefore, the cable will not connect to the electrodes as indicated in the instructions. |
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 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K082090 (Cardiac Science Corporation, 2008) has gone furthest, with 4 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 SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs. The electrodes are intended for…
Read the full statement (129 words)
The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.
The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.
The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971149: SVL-9130 Defibrillation Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971149
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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