# HeartLung Corporation

- Location (FDA's records): Houston, TX
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Product codes: QIH (2), KGI (1)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Imbio, LLC: 1 (https://510kreport.com/company/imbio)
- Philips Medical Systems (Cleveland), Inc.: 1 (https://510kreport.com/company/philips-medical-systems-cleveland)
- Image Enhancements: 1 (https://510kreport.com/company/image-enhancements)

## Firms that cite its devices most
- BunkerHill Health: 1 (https://510kreport.com/company/bunkerhill-health)

## Its most-cited devices
- K213760: ABMD Software (2022), cited by 2
- K240786: AutoChamber (2024), cited by 1

## Recent decisions
- K252029: AI-CVD (Dec 19, 2025)
- K240786: AutoChamber (Oct 10, 2024)
- K213760: ABMD Software (Jul 29, 2022)

Source page: https://510kreport.com/company/heartlung