# K252148: Butterfly Gestational Age Tool

- Pathway: 510(k) (Traditional)
- Applicant: Butterfly Network, Inc.
- Decided: Mar 27, 2026 after 261 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K935595 (1995). 278 ancestors in all.
No later device cites it as a predicate yet.
6 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232808: Butterfly iQ3 Ultrasound System, Butterfly Network, Inc. (2024) Summary page 6.

## Indications for use
The Butterfly Gestational Age Tool is indicated to provide an output of gestational age (GA) of a singleton intrauterine pregnancy presumed to be between 16-37 weeks gestation. It is for use by qualified and trained healthcare professionals in environments where healthcare is provided. This adjunctive information is not intended to be used for prenatal management and/or delivery planning. The Butterfly Gestational Age Tool is to be used with Butterfly’s ultrasound systems (iQ+ or iQ3).

Source page: https://510kreport.com/device/K252148
Methodology: https://510kreport.com/methodology