# K010281: Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBP

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Apr 9, 2002 after 434 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021217: Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBP (2002), 1 descendant of its own
- K023099: Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBP (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K010281
Methodology: https://510kreport.com/methodology