510(k) Report

510(k) · Cleared

Cleared

AU5, AU6

K000681510(k) TraditionalCleared May 3, 200065-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biosound Esaote, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 3, 2000 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 34 later devices descend from it.

Decided
May 3, 2000
Review
65 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

34 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2009: 1 descendant cleared2005: 1 descendant cleared2013: 1 descendant cleared2011: 1 descendant cleared2014: 4 descendants cleared2016: 5 descendants cleared2020: 1 descendant cleared2017: 4 descendants cleared2018: 2 descendants cleared2019: 4 descendants cleared2025: 4 descendants cleared2026: 3 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK000681 AU5, AU6Biosound Esaote, Inc. · 2000
  2. Descendant · cites it directly · 22 of its ownK132466 Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013
  3. Descendant · 2 generations on · 19 of its ownK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · Recalled
  4. Descendant · 3 generations on · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
  5. Descendant · 4 generations on · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled
  6. Descendant · 5 generations on · 8 of its ownK173291 6440 Ultrasound SystemEsaote, S.p.A. · 2018

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12009: 12011: 12013: 12014: 42016: 52017: 42018: 22019: 42020: 12021: 12023: 12025: 42026: 3
2005high 5 (2016) · low 0 (2007)2026

Most influential descendants

Showing 5 of 34 · See all
  • K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A. · 2013 · cites it directly22descendants
  • K142008Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · 2 generations on19descendants
  • K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · 3 generations on12descendants
  • K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · 4 generations on9descendants
  • K1732916440 Ultrasound SystemEsaote, S.p.A. · 2018 · 5 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000681AU5, AU6Biosound Esaote, Inc.2000—
+1K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.2013—
+2K142008Mylabseven, MylabalphaEsaote, S.p.A.20143
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.2016—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.20172
+5K1732916440 Ultrasound SystemEsaote, S.p.A.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200910
201110
201310
201440
201650
201740
201820
201940
202010
202110
202310
202540
202630
FIG. 1 — Lineage of K000681, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYO? 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (34)

See all 34

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132466Mylabseven 6400, Mylabalpha 7400Esaote, S.p.A.201322
K050551Voyager Personal Imaging DeviceArdent Sound, Inc.20058
K060800Seeker/Spark Ultrasound SystemArdent Sound, Inc.20062
K092182Voyager Compact Imaging SystemArdent Sound, Inc.20090

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?

  • Of its descendants, K132466 (Esaote, S.p.A., 2013) has gone furthest, with 22 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from Biosound Esaote, Inc.

20 FDA decisions under this applicant name. See the company

  • K023255Technos MP, Model AU6Biosound Esaote, Inc. · 2003
  • K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and Musculoskeletal…Biosound Esaote, Inc. · 2002
  • K020164E-Scan XQBiosound Esaote, Inc. · 2002
  • K012728E-Scan Mri SystemBiosound Esaote, Inc. · 2001
  • K0104057230 Ultrasound Imaging System with TeiBiosound Esaote, Inc. · 2001

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https://510kreport.com/device/K000681 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000681: AU5, AU6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000681

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026