510(k) · Cleared
ClearedMylabone Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote Europe B.V. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 31, 2010 as substantially equivalent to K083882 (Esaote Europe B.V., 2009) and 1 other predicate after an 84-day review. Its family tree reaches back 11 generations to 1993. 25 later devices descend from it.
- Decided
- Aug 31, 2010
- Review
- 84 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K924432 (1993). 81 ancestors in all, the oldest K921148 (1992). 25 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 7 generations between
- 3 generations backK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
- 2 generations backK070903 MYLAB40Esaote Europe B.V. · 2007
- 1 generation backK083882 MylabfiveEsaote Europe B.V. · 2009
- This deviceK101605 Mylabone Ultrasound SystemEsaote Europe B.V. · 2010
- Descendant · cites it directly · 24 of its ownK111302 Mylabseven, MylabalphaEsaote, S.p.A. · 2011
- Descendant · 2 generations on · 22 of its ownK132466 Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013
- Descendant · 2 generations on · 22 of its ownK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
- Descendant · 2 generations on · 19 of its ownK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · Recalled
- Descendant · 3 generations on · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
Show all 11 generations
- Root · 11 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 10 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 9 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 8 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 7 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 6 generations backK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- 5 generations backK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- 4 generations backK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
- 3 generations backK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
- 2 generations backK070903 MYLAB40Esaote Europe B.V. · 2007
- 1 generation backK083882 MylabfiveEsaote Europe B.V. · 2009
- This deviceK101605 Mylabone Ultrasound SystemEsaote Europe B.V. · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K111302Mylabseven, MylabalphaEsaote, S.p.A. · 2011 · cites it directly24descendants
- K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013 · 2 generations on22descendants
- K132231Mylabseven, MylabalphaEsaote, S.p.A. · 2013 · 2 generations on22descendants
- K142008Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · 2 generations on19descendants
- K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −10 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −9 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −8 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −7 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −6 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| −5 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| −4 | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging System | Pie Medical | 2005 | — |
| −3 | K061755 | MYLAB15/20 New Indications Ultrasound System | Esaote Europe B.V. | 2006 | — |
| −2 | K070903 | MYLAB40 | Esaote Europe B.V. | 2007 | — |
| −1 | K083882 | Mylabfive | Esaote Europe B.V. | 2009 | — |
| 0 (this device) | K101605 | Mylabone Ultrasound System | Esaote Europe B.V. | 2010 | — |
| +1 | K111302 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2011 | — |
| +2 | K132466 | Mylabseven 6400, Mylabalpha 7400 | Esaote, S.p.A. | 2013 | — |
| +2 | K132231 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2013 | — |
| +2 | K142008 | Mylabseven, Mylabalpha | Esaote, S.p.A. | 2014 | 3 |
| +3 | K153277 | 6200 Ultrasound System and 6250 Ultrasound System | Esaote, S.p.A. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 9 | 0 |
| 2000 | 9 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K083882 | MylabfiveSummary page 2…ated June 1,2010 Page 4 of 2; 5 10(k). Summary MyLabOne Esaote Europe 807.92(a)(3) Predicate Device(s) K083882 MyLabFive Esaote Europe B.V. K092058 NanoMaxx… | 2009 |
| * | K092058 | Sonosite Nanomaxx Series Ultrasound SystemSummary page 2…e 807.92(a)(3) Predicate Device(s) K083882 MyLabFive Esaote Europe B.V. K092058 NanoMaxx SonoSite, Inc. Additional substantial equivalence information is provided in… | 2009 |
What descends from it? (25)
See all 253 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 17 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 81 ancestors have a recall of any class.
- Of its descendants, K111302 (Esaote, S.p.A., 2011) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K083882.
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. 2010, 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?
Esaote's MyLabOne is an arm-held ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Obstetrics/Gynaecology, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal and Other: Urology.
The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal 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/K101605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101605: Mylabone 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/K101605
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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