510(k) · Cleared
ClearedClarius Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarius Mobile Health Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 14, 2017 as substantially equivalent to K133454 (FUJIFILM Sonosite, Inc., 2013) and 1 other predicate after a 37-day review. Its family tree reaches back 19 generations to 1995. 6 of the 235 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it.
- Decided
- Sep 14, 2017
- Review
- 37 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K935595 (1995). 212 ancestors in all, the oldest K850478 (1985). 22 later devices descend from it, 2 citing it directly. 6 of the 235 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 backK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- This deviceK172385 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017
- Descendant · cites it directly · 11 of its ownK180799 Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2018
- Descendant · 2 generations on · 10 of its ownK192107 Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2019
- Descendant · cites it directly · 9 of its ownK191235 Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020
- Descendant · 2 generations on · 8 of its ownK210432 LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2021
- Descendant · 3 generations on · 7 of its ownK222365 Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2022
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 backK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- This deviceK172385 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K180799Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2018 · cites it directly11descendants
- K192107Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2019 · 2 generations on10descendants
- K191235Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020 · cites it directly9descendants
- K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2021 · 2 generations on8descendants
- K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2022 · 3 generations on7descendants
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 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
| 0 (this device) | K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017 | — |
| +1 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2018 | — |
| +2 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2019 | — |
| +1 | K191235 | Leltek Ultrasound Imaging System | Leltek, Inc. | 2020 | — |
| +2 | K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2021 | — |
| +3 | K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2022 | — |
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 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 5 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 1 |
| 1997 | 10 | 0 |
| 1998 | 15 | 3 |
| 1999 | 17 | 0 |
| 2000 | 14 | 1 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 13 | 0 |
| 2004 | 13 | 1 |
| 2005 | 11 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K133454 | Sonosite Edge Ultrasound SystemSummary page 10…Device Name 510(k) Number FUJIFILM SonoSite Edge Ultrasound System K133454 Clarius Ultrasound System K163138 Device Description The Clarius Ultr… | 2013 |
| * | K163138 | Clarius Ultrasound SystemSummary page 10…ILM SonoSite Edge Ultrasound System K133454 Clarius Ultrasound System K163138 Device Description The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound sys… | 2016 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 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 7 companies; a new generation was cleared every 11 months on median.
- 52 of the 212 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K180799 (Clarius Mobile Health Corp., 2018) has gone furthest, with 11 descendants of its own.
- 10 other devices also cite its predicate K133454.
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 Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult)…
Read the full statement (97 words)
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler). It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), fetal echo, peripheral vessel, carotid, and procedural guidance of needles into the body.
The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.
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/K172385 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172385: Clarius Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172385
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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