Butterfly Gestational Age Tool— 510(k) K252148
Substantially EquivalentButterfly Network, Inc.
FDA 510(k) clearance K252148 for Butterfly Gestational Age Tool, Substantially Equivalent on 2026-03-27. Applicant: Butterfly Network, Inc.. Device class: 2.
Summary
Butterfly Network's Butterfly Gestational Age Tool is filed under IYN, pulsed Doppler ultrasonic imaging systems. The record doesn't describe the tool beyond its name and that code name.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Butterfly Network filed from Burlington, Massachusetts. The decision came 261 calendar days after receipt (July 9, 2025 to March 27, 2026).
Clearance details
- Applicant
- Butterfly Network, Inc.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
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More clearances from Butterfly Network, Inc.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.