510(k) Report

510(k) · Cleared

Cleared

Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System, Model M0001

K053325510(k) AbbreviatedCleared Dec 7, 20056-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

Mediwatch, Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Dec 7, 2005 after a 6-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.

Decided
Dec 7, 2005
Review
6 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared2019: 2 descendants cleared2023: 2 descendants cleared2018: 1 descendant cleared2016: 1 descendant cleared2020: 3 descendants cleared2021: 1 descendant cleared2026: 1 descendant cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK053325 Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner…Mediwatch, Ltd. · 2005
  2. Descendant · cites it directly · 16 of its ownK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
  3. Descendant · 2 generations on · 13 of its ownK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
  4. Descendant · 3 generations on · 7 of its ownK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
  5. Descendant · 3 generations on · 4 of its ownK171591 CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd. · 2017
  6. Descendant · 4 generations on · 3 of its ownK190769 Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 12013: 12016: 12017: 12018: 12019: 22020: 32021: 12023: 22025: 12026: 1
2009high 3 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 17 · See all
  • K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009 · cites it directly16descendants
  • K111021Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011 · 2 generations on13descendants
  • K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013 · 3 generations on7descendants
  • K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd. · 2017 · 3 generations on4descendants
  • K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K053325Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only)…Mediwatch, Ltd.2005—
+1K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd.2009—
+2K111021Cubescan / Biocon-700Mcube Technology Co., Ltd.2011—
+3K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd.2013—
+3K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd.2017—
+4K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201210
201310
201610
201710
201810
201920
202030
202110
202320
202510
202610
FIG. 1 — Lineage of K053325, 2005–2026Source: 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? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd.200916

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, K091518 (Mcube Technology Co., Ltd., 2009) has gone furthest, with 16 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?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Recent decisions in IYO

The IYO category page

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K053325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053325: Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan Ultrasound System, Model M0001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053325

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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