# K040056: Bio-Detek Electrode Adapter, Model R2001-90

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Detek, Inc.
- Decided: Apr 9, 2004 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: 1 generation back to K984286 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984286: Heartstream Electrode Adapter, Hewlett-Packard Co. (1998) Summary page 1.

## Indications for use
The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz Tm and stat-padz IFm Electrodes for connection with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LWFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable..

Source page: https://510kreport.com/device/K040056
Methodology: https://510kreport.com/methodology