510(k) · Cleared
ClearedSonosite Hand-Caried Untrasound System (Powerseries)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 31, 2002 as substantially equivalent to K014116 (Sonosite,Inc., 2001) and 3 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1985. 2 of the 132 devices in its family, counting itself, have a Class I recall. 124 later devices descend from it.
- Decided
- May 31, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K850478 (1985). 7 ancestors in all. 124 later devices descend from it, 5 citing it directly. 2 of the 132 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK850478 PLUS 1Dymax Corp · 1985
- 1 generation backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- This deviceK021628 Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002
- Descendant · cites it directly · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- Descendant · 2 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 3 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 43 of its ownK162549 Lumify Ultrasound SystemPhilips Health Care · 2016 · Recalled
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 124 · See all- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · cites it directly107descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 2 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 3 generations on87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 4 generations on79descendants
- K162549Lumify Ultrasound SystemPhilips Health Care · 2016 · 5 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −1 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| 0 (this device) | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | Sonosite,Inc. | 2002 | — |
| +1 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| +2 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +3 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +4 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
| +5 | K162549 | Lumify Ultrasound System | Philips Health Care | 2016 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 13 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 17 | 2 |
| 2026 | 16 | 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.
2 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? (4)
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 |
|---|---|---|---|
| * | K014116 | Hand-Carried Ultrasound SystemSummary page 2…noSite, Inc. believes that System described in this Submission is substantially equivalent to predicate devices that include the SonoSite Hand-Carried Ultrasound System (K014116) and (K010374), the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459), and the Dymax Corp.Site-Rite 3… | 2001 |
| * | K010374 | Sonosite Hand-Carried Ultrasound SystemSummary page 2…elieves that System described in this Submission is substantially equivalent to predicate devices that include the SonoSite Hand-Carried Ultrasound System (K014116) and (K010374), the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459), and the Dymax Corp.Site-Rite 3 Ultrasound Sca… | 2001 |
| * | K961459 | Level 10 HdiSummary page 2…edicate devices that include the SonoSite Hand-Carried Ultrasound System (K014116) and (K010374), the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459), and the Dymax Corp.Site-Rite 3 Ultrasound Scanner (K993624). Where applicable, this new Submission references sections of K0141… | 1997 |
| * | K993624 | Site-Rite 3 Ultrasound SystemSummary page 2…ound System (K014116) and (K010374), the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459), and the Dymax Corp.Site-Rite 3 Ultrasound Scanner (K993624). Where applicable, this new Submission references sections of K014116 to signify that the sections in this Submission remain the… | 1999 |
What descends from it? (124)
See all 1245 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 14.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K090505 (Signostics Pty, Ltd., 2009) has gone furthest, with 107 descendants of its own.
- 5 other devices also cite its predicate K014116.
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.
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 measurement of the human body as follows:
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/K021628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021628: Sonosite Hand-Caried Untrasound System (Powerseries).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021628
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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