# K971149: SVL-9130 Defibrillation Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Survivalink Corp.
- Decided: Jun 23, 1997 after 87 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914955 (1992). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914955: K-Defib/Pace Electrode, Katecho, Inc. (1992) Summary page 2.

## Cited in the summary but kept off the family tree
- K940455: Lateral Flexion Machine, Rehab, Inc. (1995). 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.

## Most influential descendants
- K082090: 9131 Defibrillation Electrodes (2008), 4 descendants of its own
- K122758: Powerheart G5 Aed (2014), 1 descendant of its own
- K143714: Powerheart G5 AED (2015), 0 descendants of its own
- K142803: Skintact, various other tradenames (2014), 0 descendants of its own
- K131494: Heart Sync (2013), 0 descendants of its own

## Recalls of this device
- Jan 23, 2008 · Not classified · Z-1616-2008: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K971149
Methodology: https://510kreport.com/methodology