510(k) · Cleared
ClearedSonosite Edge Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Sonosite, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 16, 2013 as substantially equivalent to K113156 (Sonosite,Inc., 2011) and 1 other predicate after a 34-day review. Its family tree reaches back 9 generations to 1995. 50 later devices descend from it.
- Decided
- Dec 16, 2013
- Review
- 34 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K945773 (1995). 50 ancestors in all, the oldest K891689 (1989). 50 later devices descend from it, 11 citing it directly.
- Root · 9 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 5 generations between
- 3 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 2 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 1 generation backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- This deviceK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
- Descendant · cites it directly · 46 of its ownK142017 X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014
- Descendant · cites it directly · 45 of its ownK152209 FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015
- Descendant · cites it directly · 42 of its ownK153626 SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016
- Descendant · 2 generations on · 28 of its ownK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- Descendant · cites it directly · 22 of its ownK172385 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017
Show all 9 generations
- Root · 9 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 8 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 7 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 6 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 5 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 4 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 3 generations backK082098 Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2008 · Recalled
- 2 generations backK113156 Sonosite Edge Ultrasound SystemSonosite,Inc. · 2011 · Recalled
- 1 generation backK130173 Sonosite Maxx Series Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013 · Recalled
- This deviceK133454 Sonosite Edge Ultrasound SystemFUJIFILM Sonosite, Inc. · 2013
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K142017X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2014 · cites it directly46descendants
- K152209FUJIFILM SonoSite X-Porte Ultrasound SystemFUJIFILM Sonosite, Inc. · 2015 · cites it directly45descendants
- K153626SonoSite Edge II Ultrasound SystemFUJIFILM Sonosite, Inc. · 2016 · cites it directly42descendants
- K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016 · 2 generations on28descendants
- K172385Clarius Ultrasound SystemClarius Mobile Health Corp. · 2017 · cites it directly22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −8 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −7 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −6 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −5 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −4 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −3 | K082098 | Sonosite Maxx Series Ultrasound System | Sonosite,Inc. | 2008 | 2 |
| −2 | K113156 | Sonosite Edge Ultrasound System | Sonosite,Inc. | 2011 | 1 |
| −1 | K130173 | Sonosite Maxx Series Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | 1 |
| 0 (this device) | K133454 | Sonosite Edge Ultrasound System | FUJIFILM Sonosite, Inc. | 2013 | — |
| +1 | K142017 | X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2014 | — |
| +1 | K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | FUJIFILM Sonosite, Inc. | 2015 | — |
| +1 | K153626 | SonoSite Edge II Ultrasound System | FUJIFILM Sonosite, Inc. | 2016 | — |
| +2 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
| +1 | K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 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 IYN? 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 |
|---|---|---|---|
| * | K113156 | Sonosite Edge Ultrasound SystemSummary page 1…ations System 892.2050 LLZ 3) Identification of the predicate or legally marketed device: SonoSite Edge Ultrasound System K1 13156 SonoSite Maxx Series Ultrasound System K130173 4) Device Description: The SonoSite Edge Ultrasound System is a portable… | 2011 |
| * | K130173 | Sonosite Maxx Series Ultrasound SystemSummary page 1…LLZ 3) Identification of the predicate or legally marketed device: SonoSite Edge Ultrasound System K1 13156 SonoSite Maxx Series Ultrasound System K130173 4) Device Description: The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnost… | 2013 |
What descends from it? (50)
See all 5011 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142017 | X-Porte Ultrasound System | 2014 | 46 |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | 2015 | 45 |
| K153626 | SonoSite Edge II Ultrasound System | 2016 | 42 |
| K172385 | Clarius Ultrasound System | 2017 | 22 |
| K160406 | FUJIFILM FC1 Ultrasound System | 2016 | 12 |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | 2016 | 11 |
| K171437 | SonoSite X-Porte Ultrasound System | 2017 | 7 |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | 2015 | 5 |
| K161119 | SonoSite iViz Ultrasound System | 2016 | 4 |
| K162288 | SonoSite iViz Ultrasound System | 2016 | 3 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 13 of the 50 ancestors have a recall of any class.
- Of its descendants, K142017 (FUJIFILM Sonosite, Inc., 2014) has gone furthest, with 46 descendants of its own.
- 5 other devices also cite its predicate K113156.
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. 2013, 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 SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (abdominal organs and vascular)
Intra-operative (Neuro.)
Pediatric
Small Organ (breast, thyroid, testicle, prostate)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (cardiac)
Peripheral Vessel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133454: Sonosite Edge 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/K133454
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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