# K994240: EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Apr 13, 2000 after 119 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- 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 K843707 (1985). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981083: Retrox RX 53-BP, Retrox RX 60-BP, Retrox RX 45-JBP, Retrox RX 53-JBP Model Numbers 124 396, 124 397, 124 395, 124 000, Biotronik, Inc. (1998) Summary page 1.
- K843707: Medtronic 6957J, Medtronic Vascular (1985) Summary page 1.
- K910608: Permanent Implantable FH Endocardial Leads W/Tip, Biotronik, GmbH & Co. (1991) Summary page 1.
- K980869: Synox SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , Models 120 444, 119 684, 120 438 and 120 143, Biotronik, Inc. (1998) Summary page 1.

## Most influential descendants
- K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP (2003), 0 descendants of its own

## Indications for use
BIOTRONIK’s ELOX (EX xx-BP) transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems. The ELOX (EX xx-BP) lead models are intended for placement in either the right atrium or right ventricle.

Source page: https://510kreport.com/device/K994240
Methodology: https://510kreport.com/methodology