510(k) · Cleared
ClearedSurvivalink Multifunctional Electrode (SVL-9630)
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 Dec 10, 1999 as substantially equivalent to K971149 (Survivalink Corp., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Dec 10, 1999
- Review
- 87 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K914955 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
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) | K993072 | Survivalink Multifunctional Electrode (SVL-9630) | Survivalink Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971149 | SVL-9130 Defibrillation ElectrodeSummary page 1…Class II H-1.4 Applicant Applicant’s Name: Survivalink, Corporation 5430 Feltl Road Minneapolis, MN 55343 H-2, PREDICATE DEVICE 1. Survivalink Model 9130 electrodes (K971149) 2. Katecho KDP-60 ¢electrodes (K981737) H-3. INDICATION FOR USE The SVL-9630 electrodes are single use, non sterile, and inten… | 1997 |
| Kept off the family tree | K971146 | FDA’s K971146 is Laparette Our OCR of the scanned summary read K971146, FDA’s number for Laparette (Rd Chus, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SVL-9130 electrodes”. Kept off the family tree. Summary page 2…her legally marketed electrodes for semi-automatic low power DC defibrillators. Specifically, the SVL-9130 electrode is substantially equivalent to SVL- 9130 electrodes (K971146) and Katecho’s D-Defib/Pace electrodes (K 981737). H-6. PERFORMANCE DATA The SVL-9630 clectrodes meet all the specifications for… | 1997 |
| * | K981737 | K-Defib/Pace Adult Electrode Model Number KDP-60Summary page 1…Name: Survivalink, Corporation 5430 Feltl Road Minneapolis, MN 55343 H-2, PREDICATE DEVICE 1. Survivalink Model 9130 electrodes (K971149) 2. Katecho KDP-60 ¢electrodes (K981737) H-3. INDICATION FOR USE The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low e… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 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.
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-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semni-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for cornpatibility with the proper electrode connector or…
Read the full statement (103 words)
The SVL-9630 electrodes are single use, non sterile, and intended to be used in conjunction with low energy semni-automatic external defibrillators (AED) and/or external transcutaneous pacemakers to monitor, defibrillate or pace the adult patient. The electrodes meet AAMI DF-39 performance standards. The electrodes can be used with external defibrillators/pacing devices that had been tested for cornpatibility with the proper electrode connector or adapter.
The electrodes are intended for short-term use (<8 hours) and must be used before the expiration date listed on the packaging. These electrodes provide the conductive interface between the defibnllator and/or the external transcutaneous cardiac pacemaker and the patient 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/K993072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993072: Survivalink Multifunctional Electrode (SVL-9630).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993072
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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