# P840002: Stat-Pace II

- Pathway: PMA
- Applicant: Cardiocommand, Inc.
- Decided: Apr 30, 1986 after 527 days
- Product code: LPA (System, Esophageal Pacing)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 24, 2019 · Class III · Z-1976-2019: There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.

Source page: https://510kreport.com/device/P840002
Methodology: https://510kreport.com/methodology