510(k) Report

510(k) · Cleared

Cleared

AU5 Ultrasound Imaging System

K000931510(k) TraditionalCleared Jun 8, 200078-day reviewClass II21 CFR 892.1550

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

Biosound Esaote, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jun 8, 2000 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it.

Decided
Jun 8, 2000
Review
78 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

75 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 2 descendants cleared2004: 2 descendants cleared2005: 6 descendants cleared2013: 2 descendants cleared2006: 2 descendants cleared2007: 2 descendants cleared2008: 2 descendants cleared2009: 2 descendants cleared2014: 5 descendants cleared2011: 4 descendants cleared2010: 2 descendants cleared2016: 5 descendants cleared2012: 3 descendants cleared2018: 4 descendants cleared2017: 4 descendants cleared2019: 6 descendants cleared2023: 2 descendants cleared2020: 4 descendants cleared2021: 2 descendants cleared2025: 5 descendants cleared2026: 3 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared200020052010201520202025
  1. This deviceK000931 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 2000
  2. Descendant · cites it directly · 71 of its ownK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
  3. Descendant · 2 generations on · 67 of its ownK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
  4. Descendant · 3 generations on · 66 of its ownK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
  5. Descendant · 2 generations on · 66 of its ownK023255 Technos MP, Model AU6Biosound Esaote, Inc. · 2003
  6. Descendant · 2 generations on · 64 of its ownK051837 Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 22005: 62006: 22007: 22008: 22009: 22010: 22011: 42012: 32013: 22014: 52016: 52017: 42018: 42019: 62020: 42021: 22022: 22023: 22024: 32025: 52026: 3
2002high 6 (2005) · low 0 (2015)2026

Most influential descendants

Showing 5 of 75 · 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 · 2 generations on64descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000931AU5 Ultrasound Imaging SystemBiosound Esaote, Inc.2000—
+1K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging…Biosound Esaote, Inc.2002—
+2K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A.20044
+3K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A.20051
+2K023255Technos MP, Model AU6Biosound Esaote, Inc.2003—
+2K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200420
200560
200620
200720
200820
200920
201020
201140
201230
201320
201450
201650
201740
201840
201960
202040
202120
202220
202320
202430
202550
202630
FIG. 1 — Lineage of K000931, 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 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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Biosound Esaote, Inc.200271
K023512Picus Ultrasound Imaging SystemsPie Medical200332

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, K014168 (Biosound Esaote, Inc., 2002) has gone furthest, with 71 descendants of its own.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

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

Recent decisions in IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K000931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000931: AU5 Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000931

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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