# K993072: Survivalink Multifunctional Electrode (SVL-9630)

- Pathway: 510(k) (Traditional)
- Applicant: Survivalink Corp.
- Decided: Dec 10, 1999 after 87 days
- Product code: MKJ (Automated External Defibrillators (Non-Wearable))
- Device class: 3
- Regulation: 21 CFR 870.5310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914955 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971149: SVL-9130 Defibrillation Electrode, Survivalink Corp. (1997) Summary page 1.
- K981737: K-Defib/Pace Adult Electrode Model Number KDP-60, Katecho, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K971146: Laparette, Rd Chus, Inc. (1997). 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K993072
Methodology: https://510kreport.com/methodology