# K991169: SX 53/15-BP, Model 124 853, SX 60/15-BP, Model 124 854

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Jul 1, 1999 after 85 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 K980869 (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)
- 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.

## Indications for use
Synox leads are designed for use with implantable pulse generators that require pacing leads with a bipolar 3.2 mm IS-1 connector configuration; they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pulse generator therapy is medically indicated. This indication follows that recommended in the Class | definition of the ACC/AHA Task Force Report, entitled “Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmic Devices” (JACC, Vol. 18, No. 1, July 1991:1 - 13).

Source page: https://510kreport.com/device/K991169
Methodology: https://510kreport.com/methodology