# K993139: YP 45/15-BP; YP 53/15-BP; YP 60/15-BP

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Dec 17, 1999 after 88 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 K920662 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990483: Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777, Biotronik, Inc. (1999) Summary page 1.
- K841451: Biotronik DY-Unipolar, Biotronik Sales, Inc. (1985) Summary page 1.
- K910608: Permanent Implantable FH Endocardial Leads W/Tip, Biotronik, GmbH & Co. (1991) Summary page 1.

## Cited in the summary but kept off the family tree
- K873888: Cardiac Pacemakers Inc. (CPI) Sweet Tip, bipolar, active fixation, endocardial lead. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
BIOTRONIK's YP xx/15-BP 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. The leads may be used with single or dual chamber pacing systems. The YP xx/15-BP lead models are intended for placement in either the patient’s right atrium or right ventricle.

Source page: https://510kreport.com/device/K993139
Methodology: https://510kreport.com/methodology