510(k) Report

FDA applicant

Butterfly Network, Inc.

Guildford, CT6 decisions2017–20262 recalls

FDA records 6 decisions for Butterfly Network, Inc. (Guildford, CT) from 2017 to 2026: 6 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Butterfly Network, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12020: 22023: 12024: 12026 (partial year): 1
2017high 2 (2020) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

2in 2020

2020: 2
2017high 2 (2020) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Butterfly Network, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Butterfly Network, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic4decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic2decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 188 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 20202cite it
  • K163510Poseidon Ultrasound SystemButterfly Network, Inc. · 20171cites it
  • K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · 20231cites it
  • K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · 20241cites it

What has FDA decided for it lately?

  • K252148Butterfly Gestational Age ToolButterfly Network, Inc. · 2026
  • K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · 2024
  • K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · 2023
  • K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020
  • K200980Auto 3D Bladder Volume ToolButterfly Network, Inc. · 2020
  • K163510Poseidon Ultrasound SystemButterfly Network, Inc. · 20172 recalls

All 6 as Butterfly Network, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K163510Butterfly iQ Ultrasound System containing the Auto EF (Ejection Fraction) Tool…Feb 24, 2020Class II
  • K163510Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is…Feb 24, 2020Class II