# K023205: Elox P 45-BP; Elox P 53-BP; Elox P 60-BP

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Apr 24, 2003 after 211 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: 2 generations back to K843707 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994240: EX 45-BP, Model 330 132; EX 53-BP, Model 130 018; EX 60-BP, Model 330 133, Biotronik, Inc. (2000) Summary page 1.
- K001413: Elox 45-BP, Model 330 132, Efh-27, Model 331 549, Extension Tool, Model 331 668, Biotronik, Inc. (2000). Our reading of the summary gave K001416, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BIOTRONIK's Elox 45-BP bipolar, active fixation, endocardial leads”.
- 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.
- K911122: 8MM Quantum Pulse/Suprima II Pulse Generators, Intermedics, Inc. (1991) Summary page 1.

## Indications for use
BIOTRONIK's ELOX P 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 P lead models are intended for placement in either the right atrium or right ventricle

Source page: https://510kreport.com/device/K023205
Methodology: https://510kreport.com/methodology