510(k) Report

510(k) · Cleared

Cleared

Hudson 2020, 2040, 2060,Ultrasound Scanners

K022928510(k) TraditionalCleared Dec 11, 200298-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

Hudson Diagnostic Imaging, LLC · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Dec 11, 2002 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 60 later devices descend from it.

Decided
Dec 11, 2002
Review
98 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2015: 1 descendant cleared2018: 7 descendants cleared2016: 5 descendants cleared2017: 1 descendant cleared2019: 7 descendants cleared2020: 6 descendants cleared2022: 8 descendants cleared2021: 8 descendants cleared2023: 5 descendants cleared2024: 5 descendants cleared2026: 4 descendants cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK022928 Hudson 2020, 2040, 2060,Ultrasound ScannersHudson Diagnostic Imaging, LLC · 2002
  2. Descendant · cites it directly · 58 of its ownK142368 Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · Recalled
  3. Descendant · 2 generations on · 50 of its ownK171048 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
  4. Descendant · 3 generations on · 39 of its ownK173204 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
  5. Descendant · 2 generations on · 32 of its ownK173513 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · Recalled
  6. Descendant · 3 generations on · 31 of its ownK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

2004: 12015: 12016: 52017: 12018: 72019: 72020: 62021: 82022: 82023: 52024: 52025: 22026: 4
2004high 8 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 60 · See all
  • K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd. · 2015 · cites it directly58descendants
  • K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 2 generations on50descendants
  • K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 3 generations on39descendants
  • K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 2 generations on32descendants
  • K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 3 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022928Hudson 2020, 2040, 2060,Ultrasound ScannersHudson Diagnostic Imaging, LLC2002—
+1K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.20151
+2K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2017—
+3K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018—
+2K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20181
+3K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201510
201650
201710
201870
201970
202060
202180
202280
202350
202450
202520
202640
FIG. 1 — Lineage of K022928, 2002–2026Source: 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), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (60)

See all 60

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

NumberDeviceApplicantDecidedDescendants
K142368Noblus Diagnostic Ultrasound ScannerHitachi Aloka Medical, Ltd.201558
K041675Picus, Parus, Falco and Aquila Ultrasound SystemsPie Medical20040

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, K142368 (Hitachi Aloka Medical, Ltd., 2015) has gone furthest, with 58 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—

What is it indicated for?

High resolution ultrasound imaging of wounds such as: Clean, closed surgical incisions Skin graft donor sites Superficial wounds such as abrasion, skin tears, and blisters Chafed skin or irritated skin Ulcers-cavernous and non-cavernous High resolution ultrasound imaging of wounds such as: Clean, closed surgical incisions Skin graft donor sites Superficial wounds such as abrasion, skin tears, and blisters Chafed skin or irritated skin Ulcers-cavernous…

Read the full statement (99 words)

High resolution ultrasound imaging of wounds such as:

Clean, closed surgical incisions

Skin graft donor sites

Superficial wounds such as abrasion, skin tears, and blisters

Chafed skin or irritated skin

Ulcers-cavernous and non-cavernous

High resolution ultrasound imaging of wounds such as:

Clean, closed surgical incisions

Skin graft donor sites

Superficial wounds such as abrasion, skin tears, and blisters

Chafed skin or irritated skin

Ulcers-cavernous and non-cavernous

High resolution ultrasound imaging of wounds such as:

Clean, closed surgical incisions

Skin graft donor sites

Superficial wounds such as abrasion, skin tears, and blisters

Chafed skin or irritated skin

Ulcers--cavernous and non-cavernous

Indications for use as stated in the FDA 510(k) statement.

More from Hudson Diagnostic Imaging, LLC

2 FDA decisions under this applicant name. See the company

  • K040926Ultrasound Scanner, Hudson Models 8000 and 9000Hudson Diagnostic Imaging, LLC · 2004

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https://510kreport.com/device/K022928 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022928: Hudson 2020, 2040, 2060,Ultrasound Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022928

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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