510(k) · Cleared
Recalled · Class II · 2020Poseidon Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Butterfly Network, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 6, 2017 as substantially equivalent to K162549 (Philips Health Care, 2016) after a 265-day review. Its family tree reaches back 19 generations to 1995. 6 of the 181 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 6, 2017
- Review
- 265 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 19 generations to K935595 (1995). 174 ancestors in all, the oldest K850478 (1985). 6 later devices descend from it, 1 citing it directly. 6 of the 181 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 15 generations between
- 3 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 2 generations backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- 1 generation backK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
- This deviceK163510 Poseidon Ultrasound SystemButterfly Network, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK202406 Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK220068 Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK232808 Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK211527 Exo IrisExo Imaging, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK252148 Butterfly Gestational Age ToolButterfly Network, Inc. · 2026
Show all 19 generations
- Root · 19 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 18 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 17 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 16 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 15 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 14 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 13 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 12 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 10 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 9 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 8 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 7 generations backK102041 AixplorerSupersonic Imagine · 2010
- 6 generations backK112255 AixplorerSupersonic Imagine · 2012
- 5 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 4 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 3 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 2 generations backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- 1 generation backK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
- This deviceK163510 Poseidon Ultrasound SystemButterfly Network, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K202406Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020 · cites it directly5descendants
- K220068Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · 2023 · 2 generations on2descendants
- K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · 2024 · 3 generations on1descendant
- K211527Exo IrisExo Imaging, Inc. · 2021 · 2 generations on1descendant
- K252148Butterfly Gestational Age ToolButterfly Network, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −18 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −17 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −16 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −15 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −14 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −13 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −12 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −10 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −9 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −8 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −7 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −6 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −5 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −4 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| −3 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| −2 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| −1 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
| 0 (this device) | K163510 | Poseidon Ultrasound System | Butterfly Network, Inc. | 2017 | — |
| +1 | K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | 2020 | — |
| +2 | K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | 2023 | — |
| +3 | K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | 2024 | — |
| +2 | K211527 | Exo Iris | Exo Imaging, Inc. | 2021 | — |
| +4 | K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 1 |
| 1997 | 9 | 0 |
| 1998 | 13 | 3 |
| 1999 | 16 | 0 |
| 2000 | 14 | 1 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 9 | 0 |
| 2004 | 11 | 1 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162549 | Lumify Ultrasound SystemSummary page 6…System 892.1560 90-IYO Diagnostic Ultrasound Transducer 892.1570 90-ITX Classification Class II Predicate Device: K162549 – Philips Healthcare, Lumify Ultrasound System (Clearance Date:… | 2016 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202406 | Butterfly iQ Ultrasound System | 2020 | 5 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2020 | Class II | Z-1601-2020 | No Marketing Application | Distributed without an approved 510(k) |
| Feb 24, 2020 | Class II | Z-1600-2020 | No Marketing Application | Distributed without an approved 510(k) |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 7 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 7 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 45 of the 174 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K202406 (Butterfly Network, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K162549.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163510: Poseidon Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163510
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026