# K910237: Modified Model 5330 AV Demand Pulse Generator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Feb 25, 1991 after 38 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K020896: Oscor Pace 203/Pace 203H Dual-Chamber Temporary Pacemaker, ST. Jude Medical, Model 3085 Dual-Chamber External Pulse Gene (2002), 2 descendants of its own
- K022939: Oscor Pace 101/101H and Accessories, ST.Jude Medical Model 3077 and Accessories,Cardiotronic Pace 101 and Accessories (2002), 1 descendant of its own
- K033130: Pace 101/Pace 101H, Model 3077 Ssi Temporary Pulse Generator (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K910237
Methodology: https://510kreport.com/methodology
