Butterfly Gestational Age Tool

K252148

Butterfly Network, Inc. · cleared 2026-03-27 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The Butterfly Gestational Age Tool (GA Tool) is a software application that guides trained healthcare professionals through measuring fundal height and obtaining ultrasound cines of a patient's gravid abdomen, using a Butterfly ultrasound probe (iQ+ or iQ3) connected to a tablet.”
AlgorithmDeep Learning
source quote (p.8)
“The Butterfly GA tool uses Deep Learning (DL)”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Similarly, since there are no changes to the general Butterfly platform, there is no impact to cybersecurity requirements.”

Validation studies (1)

Retrospective clinical

n=111 patients · 4 site(s)

endpoints: Butterfly GA Tool error in reference to the Gestational Age calculation from Last Menstrual Period (LMP); Bland-Altman bias and Limits of Agreement (LOA) for the Butterfly GA Tool and Biometry against LMP; Bland-Altman bias and Limits of Agreement (LOA) for the Butterfly GA Tool against Biometry

standards: IEC 60601-1 Ed. 3.2 en: 2020, IEC 60601-1-11 Ed. 2.1 b:2020, IEC 60601-1-12 Ed. 1.1 b:2020, IEC 60601-2-5 Ed 3.0 2009-07, IEC 60601-2-37 Ed. 2.0 b: 2007, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, ISO 13485

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
4
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97843

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97726

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96992

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95254

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252148