# Butterfly Network, Inc.

- Location (FDA's records): Guildford, CT
- FDA decisions: 6 (2017–2026): 6 510(k) clearances
- Product codes: IYN (4), IYO (2)
- 510(k) review time since 2016: median 188 days, against 95 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Verathon Incorporated: 1 (https://510kreport.com/company/verathon)
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagnostics)
- Philips Health Care: 1 (https://510kreport.com/company/philips-health-care)

## Firms that cite its devices most
- Exo Imaging: 1 (https://510kreport.com/company/exo-imaging)

## Its most-cited devices
- K202406: Butterfly iQ Ultrasound System (2020), cited by 2
- K163510: Poseidon Ultrasound System (2017), cited by 1
- K220068: Butterfly iQ/iQ+ Ultrasound System (2023), cited by 1
- K232808: Butterfly iQ3 Ultrasound System (2024), cited by 1

## Recent decisions
- K252148: Butterfly Gestational Age Tool (Mar 27, 2026)
- K232808: Butterfly iQ3 Ultrasound System (Jan 4, 2024)
- K220068: Butterfly iQ/iQ+ Ultrasound System (Mar 31, 2023)
- K202406: Butterfly iQ Ultrasound System (Sep 16, 2020)
- K200980: Auto 3D Bladder Volume Tool (Jun 11, 2020)
- K163510: Poseidon Ultrasound System (Sep 6, 2017)

Source page: https://510kreport.com/company/butterfly-network