510(k) Report

510(k) · Cleared

Cleared

4000 AU Ultrasound Imaging System

K944485510(k) TraditionalCleared May 24, 1995253-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, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 24, 1995 after a 253-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 87 later devices descend from it.

Decided
May 24, 1995
Review
253 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

87 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1996: 1 descendant cleared1998: 1 descendant cleared2006: 3 descendants cleared2005: 6 descendants cleared2009: 3 descendants cleared1999: 1 descendant cleared2011: 5 descendants cleared2014: 6 descendants cleared2002: 1 descendant cleared2013: 2 descendants cleared2004: 1 descendant cleared2003: 1 descendant cleared2008: 2 descendants cleared2010: 2 descendants cleared2016: 6 descendants cleared2020: 5 descendants cleared2017: 5 descendants cleared2007: 2 descendants cleared2012: 3 descendants cleared2018: 4 descendants cleared2025: 6 descendants cleared2019: 6 descendants cleared2026: 5 descendants cleared2023: 2 descendants cleared2021: 2 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared1995200020052010201520202025
  1. This deviceK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
  2. Descendant · cites it directly · 85 of its ownK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
  3. Descendant · 2 generations on · 83 of its ownK990360 AU6Biosound Esaote, Inc. · 1999
  4. Descendant · 3 generations on · 71 of its ownK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
  5. Descendant · 4 generations on · 67 of its ownK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
  6. Descendant · 5 generations on · 66 of its ownK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

1996: 11998: 11999: 12001: 12002: 12003: 12004: 12005: 62006: 32007: 22008: 22009: 32010: 22011: 52012: 32013: 22014: 62016: 62017: 52018: 42019: 62020: 52021: 22022: 22023: 22024: 32025: 62026: 5
1996high 6 (2005) · low 0 (1997)2026

Most influential descendants

Showing 5 of 87 · See all
  • K980468AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998 · cites it directly85descendants
  • K990360AU6Biosound Esaote, Inc. · 1999 · 2 generations on83descendants
  • K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Biosound Esaote, Inc. · 2002 · 3 generations on71descendants
  • K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · 4 generations on67descendants
  • K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · 5 generations on66descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K9444854000 AU Ultrasound Imaging SystemBiosound, Inc.1995—
+1K980468AU5 Ultrasound Imaging SystemBiosound Esaote, Inc.1998—
+2K990360AU6Biosound Esaote, Inc.1999—
+3K014168AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging…Biosound Esaote, Inc.2002—
+4K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A.20044
+5K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
199910
200110
200210
200310
200410
200560
200630
200720
200820
200930
201020
201150
201230
201320
201460
201660
201750
201840
201960
202050
202120
202220
202320
202430
202560
202650
FIG. 1 — Lineage of K944485, 1995–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (87)

See all 87

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

NumberDeviceApplicantDecidedDescendants
K980468AU5 Ultrasound Imaging SystemBiosound Esaote, Inc.199885
K013142DiasusDynamic Imaging, Ltd.200110
K953530Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-aBiosound, Inc.19960

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, K980468 (Biosound Esaote, Inc., 1998) has gone furthest, with 85 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, Inc.

39 FDA decisions under this applicant name. See the company

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  • K963936Accesspoint, Med E-Mail, Dicom ReaderBiosound, Inc. · 1997
  • K963262Artoscan MBiosound, Inc. · 1997
  • K963662Galileo Evoked PotentialreBiosound, Inc. · 1997
  • K953716Intracavity TransducersBiosound, Inc. · 1996

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https://510kreport.com/device/K944485 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944485: 4000 AU Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944485

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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