510(k) · Cleared
ClearedButterfly iQ/iQ+ Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Butterfly Network, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 31, 2023 as substantially equivalent to K202406 (Butterfly Network, Inc., 2020) after a 445-day review. Its family tree reaches back 24 generations to 1995. 6 of the 279 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Mar 31, 2023
- Review
- 445 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K935595 (1995). 276 ancestors in all, the oldest K850478 (1985). 2 later devices descend from it, 1 citing it directly. 6 of the 279 devices in this family, counting this one, have a Class I recall.
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations between
- 3 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 2 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 1 generation backK202406 Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020
- This deviceK220068 Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK232808 Butterfly iQ3 Ultrasound SystemButterfly Network, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK252148 Butterfly Gestational Age ToolButterfly Network, Inc. · 2026
Show all 24 generations
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 22 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 21 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 20 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 19 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 18 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 15 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 14 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 13 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 12 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 11 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 10 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 9 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 8 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 7 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 6 generations backK141639 Voluson S6, Voluson S8GE Healthcare · 2014
- 5 generations backK143452 Logiq P9, Logiq P7GE Healthcare · 2015
- 4 generations backK161047 LOGIQ P9 and LOGIQ P7GE Healthcare · 2016
- 3 generations backK163596 LOGIQ P9 and LOGIQ P7GE Healthcare · 2017
- 2 generations backK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
- 1 generation backK202406 Butterfly iQ Ultrasound SystemButterfly Network, Inc. · 2020
- This deviceK220068 Butterfly iQ/iQ+ Ultrasound SystemButterfly Network, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −23 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −22 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −21 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −20 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −19 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −18 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −15 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −14 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −13 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −12 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −11 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −10 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −9 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −8 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −7 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −6 | K141639 | Voluson S6, Voluson S8 | GE Healthcare | 2014 | — |
| −5 | K143452 | Logiq P9, Logiq P7 | GE Healthcare | 2015 | — |
| −4 | K161047 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2016 | — |
| −3 | K163596 | LOGIQ P9 and LOGIQ P7 | GE Healthcare | 2017 | — |
| −2 | K170714 | Venue | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | — |
| −1 | K202406 | Butterfly iQ Ultrasound System | Butterfly Network, Inc. | 2020 | — |
| 0 (this device) | K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | 2023 | — |
| +1 | K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | 2024 | — |
| +2 | 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 | 8 | 0 |
| 1996 | 7 | 1 |
| 1997 | 11 | 0 |
| 1998 | 14 | 3 |
| 1999 | 16 | 0 |
| 2000 | 15 | 1 |
| 2001 | 16 | 0 |
| 2002 | 20 | 0 |
| 2003 | 18 | 0 |
| 2004 | 16 | 1 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 11 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K202406 | Butterfly iQ Ultrasound SystemSummary page 4…mary Product Code: IYN Secondary Product Codes: IYO, ITX, QIH Classification Panel: Radiology III. PREDICATE DEVICE Primary Predicate: Butterfly iQ Ultrasound System (K202406) This predicate has not been subject to a design-related recall. Reference Predicates: Philips Lumify Diagnostic Ultrasound Syst… | 2020 |
| † | K203406 | Lumify Diagnostic Ultrasound System | 2021 |
| † | K170714 | Venue | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232808 | Butterfly iQ3 Ultrasound System | 2024 | 1 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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 · 9 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 9 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 9 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 28 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 81 of the 276 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K232808 (Butterfly Network, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K202406.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Butterfly iQ/Butterfly iQ+ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided 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, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid…
Read the full statement (93 words)
The Butterfly iQ/Butterfly iQ+ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided 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, deep vein thrombosis and arterial studies), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode, B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220068: Butterfly iQ/iQ+ 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/K220068
Report an extraction error
Are you the manufacturer?
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