# K163510: Poseidon Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Butterfly Network, Inc.
- Decided: Sep 6, 2017 after 265 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K935595 (1995). 174 ancestors in all.
6 later devices descend from it; 1 cites it directly.
6 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162549: Lumify Ultrasound System, Philips Health Care (2016) Summary page 6.

## Most influential descendants
- K202406: Butterfly iQ Ultrasound System (2020), 5 descendants of its own
- K220068: Butterfly iQ/iQ+ Ultrasound System (2023), 2 descendants of its own
- K232808: Butterfly iQ3 Ultrasound System (2024), 1 descendant of its own
- K211527: Exo Iris (2021), 1 descendant of its own
- K252148: Butterfly Gestational Age Tool (2026), 0 descendants of its own

## Recalls of this device
- Feb 24, 2020 · Class II · Z-1601-2020: Distributed without an approved 510(k)
- Feb 24, 2020 · Class II · Z-1600-2020: Distributed without an approved 510(k)

## Indications for use
The Poseidon Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid and arterial studies), Procedural Guidance, Small Organs (including thyroid), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional) and Musculoskeletal (superficial).

Source page: https://510kreport.com/device/K163510
Methodology: https://510kreport.com/methodology