# K123916: Psa Series

- Pathway: 510(k) (Traditional)
- Applicant: Osypka Medical, Inc.
- Decided: Apr 9, 2013 after 111 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- 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 K883930 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964190: Era 300 Dual Chamber Pacing System Analyzer, Biotronik, Inc. (1997) Summary page 1.

## Indications for use
This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.

Source page: https://510kreport.com/device/K123916
Methodology: https://510kreport.com/methodology