Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Butterfly Network, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
261 daysmedian FDA review time
445 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | 2026-03-27 | 261 | 0 |
| K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | 2024-01-04 | 114 | 0 |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | 2023-03-31 | 445 | 0 |
| K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | 2020-09-16 | 26 | 0 |
| K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | 2020-06-11 | 58 | 0 |
| K163510 | Poseidon Ultrasound System | Butterfly Network, Inc. | 2017-09-06 | 265 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda