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 Nov 30, 2016 as substantially equivalent to K151339 (Healcerion Co., Ltd., 2015) and 2 other predicates after a 21-day review. Its family tree reaches back 18 generations to 1995. 6 of the 240 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Nov 30, 2016
- Review
- 21 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K935595 (1995). 211 ancestors in all, the oldest K850478 (1985). 28 later devices descend from it, 3 citing it directly. 6 of the 240 devices in this family, counting this one, have a Class I recall.
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 14 generations between
- 3 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 2 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 1 generation backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- This deviceK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- Descendant · cites it directly · 22 of its ownK172385 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017
- Descendant · 2 generations on · 11 of its ownK180799 Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2018
- Descendant · 3 generations on · 10 of its ownK192107 Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2019
- Descendant · 2 generations on · 9 of its ownK191235 Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020
- Descendant · 3 generations on · 8 of its ownK210432 LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2021
Show all 18 generations
- Root · 18 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 16 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 15 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 14 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 13 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 12 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 11 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 10 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 9 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 8 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 7 generations backK091970 Aixplorer Ultrasound SystemSupersonic Imagine · 2009
- 6 generations backK102041 AixplorerSupersonic Imagine · 2010
- 5 generations backK112255 AixplorerSupersonic Imagine · 2012
- 4 generations backK130499 IU22 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 3 generations backK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- 2 generations backK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- 1 generation backK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- This deviceK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K172385Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017 · cites it directly22descendants
- K180799Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2018 · 2 generations on11descendants
- K192107Clarius Ultrasound ScannerClarius Mobile Health Corp. · 2019 · 3 generations on10descendants
- K191235Leltek Ultrasound Imaging SystemLeltek, Inc. · 2020 · 2 generations on9descendants
- K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc. · 2021 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −17 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −16 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −15 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −14 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −13 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −12 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −11 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −10 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −9 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −8 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −7 | K091970 | Aixplorer Ultrasound System | Supersonic Imagine | 2009 | — |
| −6 | K102041 | Aixplorer | Supersonic Imagine | 2010 | — |
| −5 | K112255 | Aixplorer | Supersonic Imagine | 2012 | — |
| −4 | K130499 | IU22 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 2 |
| −3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| −2 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| −1 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| 0 (this device) | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
| +1 | K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017 | — |
| +2 | K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2018 | — |
| +3 | K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2019 | — |
| +2 | K191235 | Leltek Ultrasound Imaging System | Leltek, Inc. | 2020 | — |
| +3 | K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Leltek, Inc. | 2021 | — |
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 |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C)Summary page 7…s: Device Name 510(k) Number SONON Ultrasound Imaging System (Model: SONON 300C) K151339 Philips Lumify Diagnostic Ultrasound System K152899 FUJIFILM SonoSite Edge II Ultrasound System.… | 2015 |
| * | K152899 | Philips Lumify Diagnostic Ultrasound SystemSummary page 7…k) Number SONON Ultrasound Imaging System (Model: SONON 300C) K151339 Philips Lumify Diagnostic Ultrasound System K152899 FUJIFILM SonoSite Edge II Ultrasound System. K153626 (K153626)… | 2015 |
| * | K153626 | SonoSite Edge II Ultrasound SystemSummary page 7…K151339 Philips Lumify Diagnostic Ultrasound System K152899 FUJIFILM SonoSite Edge II Ultrasound System. K153626 (K153626) PAGE 1 OF 6 1. Device Description T… | 2016 |
What descends from it? (28)
See all 283 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 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 6 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 21 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 52 of the 211 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K172385 (Clarius Mobile Health Corp., 2017) has gone furthest, with 22 descendants of its own.
- 4 other devices also cite its predicate K151339.
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. 2016, 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?
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures. Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other…
Read the full statement (117 words)
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Additional Comments: Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and imaging guidance for nerve block procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163138: Clarius Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163138
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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