# Lungpacer Medical USA, Inc.

- Location (FDA's records): Exton
- FDA decisions: 1 (2024–2024): 1 original PMA approval
- Product codes: SDL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- P240012: AeroPace® System (Dec 4, 2024)

Source page: https://510kreport.com/company/lungpacer-medical-usa