# K033771: Bio-Detek Modified Adult Multi-Function Electrode with Connector

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Feb 27, 2004 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K931801: Multi-Dop X, Dantec Medical, Inc. (1995). Our reading of the summary gave K931801, FDA’s number for Multi-Dop X (Dantec Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BIO-DETEK Adult Multi-Function Electrodes”. Kept off the family tree. Summary page 1.

## Recalls of this device
- Mar 12, 2013 · Class II · Z-2565-2014: Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators

## Indications for use
The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 1OC, LIFEPAK I1, LWEPAK 500, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cables, for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.

Source page: https://510kreport.com/device/K033771
Methodology: https://510kreport.com/methodology