510(k) · Cleared
ClearedAU6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound Esaote, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 30, 1999 as substantially equivalent to K980468 (Biosound Esaote, Inc., 1998) after an 84-day review. Its family tree reaches back 2 generations to 1995. 83 later devices descend from it.
- Decided
- Apr 30, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944485 (1995). 83 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 1 generation backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- This deviceK990360 AU6Biosound Esaote, Inc. · 1999
- Descendant · cites it directly · 71 of its ownK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
- Descendant · 2 generations on · 67 of its ownK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
- Descendant · 3 generations on · 66 of its ownK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
- Descendant · 2 generations on · 66 of its ownK023255 Technos MP, Model AU6Biosound Esaote, Inc. · 2003
- Descendant · cites it directly · 64 of its ownK051837 Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Biosound Esaote, Inc. · 2002 · cites it directly71descendants
- K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · 2 generations on67descendants
- K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · 3 generations on66descendants
- K023255Technos MP, Model AU6Biosound Esaote, Inc. · 2003 · 2 generations on66descendants
- K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005 · cites it directly64descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −1 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| 0 (this device) | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| +1 | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging… | Biosound Esaote, Inc. | 2002 | — |
| +2 | K040596 | Ultrasound Imaging System, Model 7300 | Esaote, S.p.A. | 2004 | 4 |
| +3 | K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote, S.p.A. | 2005 | 1 |
| +2 | K023255 | Technos MP, Model AU6 | Biosound Esaote, Inc. | 2003 | — |
| +1 | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100 | Esaote, S.p.A. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K980468 | AU5 Ultrasound Imaging SystemSummary page 1…nd Imaging System Classification Name(s): System, Imaging, Pulsed Doppler, Ultrasonic Classification Number: 90IYN; 90I' YO 807.92(a)(3) Predicate Device(s) Esaote AUS K980468 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. Page 3 =… | 1998 |
What descends from it? (83)
See all 834 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K014168 (Biosound Esaote, Inc., 2002) has gone furthest, with 71 descendants of its own.
- 4 other devices also cite its predicate K980468.
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?
The AU6 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.
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/K990360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990360: AU6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990360
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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