510(k) · Cleared
ClearedFibroScan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echosens · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 1, 2015 as substantially equivalent to K123806 (Echosens, 2013) and 1 other predicate after a 211-day review. Its family tree reaches back 15 generations to 1995. 25 later devices descend from it.
- Decided
- Sep 1, 2015
- Review
- 211 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K935595 (1995). 76 ancestors in all, the oldest K891689 (1989). 25 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations between
- 3 generations backK102041 AixplorerSupersonic Imagine · 2010
- 2 generations backK112255 AixplorerSupersonic Imagine · 2012
- 1 generation backK123806 FibroscanEchosens · 2013
- This deviceK150239 FibroScanEchosens · 2015
- Descendant · cites it directly · 14 of its ownK181547 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and…Echosens · 2018
- Descendant · 2 generations on · 9 of its ownK203273 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430…Echosens · 2021
- Descendant · cites it directly · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018
- Descendant · 3 generations on · 5 of its ownK212035 FibroScan 230Echosens · 2021
Show all 15 generations
- Root · 15 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 13 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 12 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 11 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 8 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 7 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 6 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 5 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 3 generations backK102041 AixplorerSupersonic Imagine · 2010
- 2 generations backK112255 AixplorerSupersonic Imagine · 2012
- 1 generation backK123806 FibroscanEchosens · 2013
- This deviceK150239 FibroScanEchosens · 2015
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)Echosens · 2018 · cites it directly14descendants
- K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)Echosens · 2021 · 2 generations on9descendants
- K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · cites it directly9descendants
- K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 2 generations on8descendants
- K212035FibroScan 230Echosens · 2021 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −14 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −13 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −12 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −11 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −9 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −8 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −7 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −6 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −5 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −3 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −2 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −1 | K123806 | Fibroscan | Echosens | 2013 | — |
| 0 (this device) | K150239 | FibroScan | Echosens | 2015 | — |
| +1 | K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | 2018 | — |
| +2 | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and… | Echosens | 2021 | — |
| +1 | K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2017 | 2 |
| +2 | K173291 | 6440 Ultrasound System | Esaote, S.p.A. | 2018 | — |
| +3 | K212035 | FibroScan 230 | Echosens | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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.
Planning a device in IYO? 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? (2)
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 |
|---|---|---|---|
| * | K123806 | FibroscanSummary page 8…lishment Registration Number: 3010258456 Predicate Device This submission claims substantial equivalence to a combination of two cleared devices: 1. FibroScan® (#K123806) manufactured by the sponsor and cleared on April 5, 2013; and 2. Aixplorer® (#K132274) manufactured by Supersonic Imagine S.A. a… | 2013 |
| * | K132274 | AixplorerSummary page 8…s substantial equivalence to a combination of two cleared devices: 1. FibroScan® (#K123806) manufactured by the sponsor and cleared on April 5, 2013; and 2. Aixplorer® (#K132274) manufactured by Supersonic Imagine S.A. and cleared on September 24, 2013.… | 2013 |
What descends from it? (25)
See all 252 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 18 of the 76 ancestors have a recall of any class.
- Of its descendants, K181547 (Echosens, 2018) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K123806.
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. 2015, 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 FibroScan® system is intended to provide SOHz shear wave speed measurements and estimates of tissue stiffness through internal structures of the body.
FibroScan® is indicated for noninvasive measurement of shear wave speed and estimate of stiffness at 50 Hz in the liver. The shear wave speed may be used as an aid to clinical management of pediatric and adult patients with liver disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150239: FibroScan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150239
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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