510(k) · Cleared
ClearedHand-Carried Ultrasound System
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 Dec 20, 2001 as substantially equivalent to K010374 (Sonosite,Inc., 2001) and 2 other predicates after a 6-day review. Its family tree reaches back 1 generation to 1997. 2 of the 437 devices in its family, counting itself, have a Class I recall. 433 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 6 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K961459 (1997). 3 ancestors in all. 433 later devices descend from it, 6 citing it directly. 2 of the 437 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
- This deviceK014116 Hand-Carried Ultrasound SystemSonosite,Inc. · 2001
- Descendant · cites it directly · 339 of its ownK101757 Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series…Sonosite,Inc. · 2010
- Descendant · cites it directly · 124 of its ownK021628 Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002
- Descendant · 2 generations on · 116 of its ownK113647 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011
- Descendant · 3 generations on · 107 of its ownK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
Showing 5 of 433 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 433 · See all- K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2010 · cites it directly339descendants
- K021628Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002 · cites it directly124descendants
- K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011 · 2 generations on116descendants
- K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 3 generations on107descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 2 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961459 | Level 10 Hdi | Advanced Technology Laboratories, Inc. | 1997 | — |
| 0 (this device) | K014116 | Hand-Carried Ultrasound System | Sonosite,Inc. | 2001 | — |
| +1 | K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound… | Sonosite,Inc. | 2010 | — |
| +1 | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | Sonosite,Inc. | 2002 | — |
| +2 | K113647 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011 | — |
| +3 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 9 | 0 |
| 2013 | 14 | 0 |
| 2014 | 16 | 0 |
| 2015 | 25 | 0 |
| 2016 | 27 | 0 |
| 2017 | 36 | 0 |
| 2018 | 30 | 0 |
| 2019 | 29 | 0 |
| 2020 | 33 | 0 |
| 2021 | 38 | 0 |
| 2022 | 30 | 0 |
| 2023 | 27 | 0 |
| 2024 | 35 | 0 |
| 2025 | 41 | 2 |
| 2026 | 29 | 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? (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 |
|---|---|---|---|
| * | K010374 | Sonosite Hand-Carried Ultrasound SystemSummary page 2…ed device: SonoSite, Inc. believes that System described in this Submission is substantially equivalent to a combination of the SonoSite Hand-Carried Ultrasound System (K010374), (K003399) and the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459). Where applicable, this new Subm… | 2001 |
| * | K003399 | Sonosite Hand-Carried Ultrasound SystemSummary page 2…SonoSite, Inc. believes that System described in this Submission is substantially equivalent to a combination of the SonoSite Hand-Carried Ultrasound System (K010374), (K003399) and the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459). Where applicable, this new Submission refe… | 2000 |
| * | K961459 | Level 10 HdiSummary page 2…uivalent to a combination of the SonoSite Hand-Carried Ultrasound System (K010374), (K003399) and the Advanced Technology Laboratories (ATL) HDI® 5000 Ultrasound System (K961459). Where applicable, this new Submission references sections of K010374 and K003399 to signify that the sections remain the same a… | 1997 |
What descends from it? (433)
See all 4336 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System | 2010 | 339 |
| K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | 2002 | 124 |
| K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System… | 2003 | 13 |
| K043452 | Titan High Resolution Ultrasound System and Sonosite Ultrasound System | 2004 | 11 |
| K090059 | Imago C21 Diagnostic Ultrasound System | 2009 | 1 |
| K023957 | Sonosite Hand-Carried Ultrasound System (C2 Series) | 2002 | 0 |
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?
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 analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis 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/K014116 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014116: Hand-Carried Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014116
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026