Butterfly Network, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Butterfly Network, Inc.” (first 2017, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 188 days. Since 2017 the median was 188 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 42 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 445 |
| 2024 | 1 | 114 |
| 2025 | 0 | — |
| 2026 | 1 | 261 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Butterfly Network, Inc. took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
Review panels
- Radiology (6)
Most recent Butterfly Network, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252148 | Butterfly Gestational Age Tool | IYN | 2026-03-27 | 261 |
| K232808 | Butterfly iQ3 Ultrasound System | IYN | 2024-01-04 | 114 |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | IYO | 2023-03-31 | 445 |
| K202406 | Butterfly iQ Ultrasound System | IYN | 2020-09-16 | 26 |
| K200980 | Auto 3D Bladder Volume Tool | IYO | 2020-06-11 | 58 |
| K163510 | Poseidon Ultrasound System | IYN | 2017-09-06 | 265 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2020-02-24.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Butterfly Network, Inc. (BFLY): EDGAR filings, CIK 1804176. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Butterfly Network, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Butterfly Network, Inc.” (first 2017, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Butterfly Network, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Butterfly Network, Inc. is 188 days. Since 2017: 188 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Butterfly Network, Inc.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2).
Next steps
- See all 6 Butterfly Network, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Butterfly Network, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.