510(k) · Cleared
ClearedBladder Scanner (Model: M3, M3-HD, M4, M4-HD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Peaksonic Medical Technology Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 26, 2021 as substantially equivalent to K190769 (Suzhou Lischka Medtech Co., Ltd., 2019) after a 284-day review. Its family tree reaches back 8 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 26, 2021
- Review
- 284 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K915436 (1992). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 7 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 6 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- 5 generations backK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- 4 generations backK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
- 3 generations backK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
- 2 generations backK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
- 1 generation backK190769 Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019
- This deviceK201316 Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK250331 Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK230986 Bladder ScannerAvantsonic Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −7 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −6 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| −5 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| −4 | K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | Mcube Technology Co., Ltd. | 2009 | — |
| −3 | K111021 | Cubescan / Biocon-700 | Mcube Technology Co., Ltd. | 2011 | — |
| −2 | K131227 | Padscan HD Series Bladder Scanner | Carenoso Technology Co., Ltd. | 2013 | — |
| −1 | K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | Suzhou Lischka Medtech Co., Ltd. | 2019 | — |
| 0 (this device) | K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021 | — |
| +1 | K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025 | — |
| +1 | K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W)Summary page 4…Transducer, Ultrasonic, Diagnostic Regulation Class: Class II Product Code: IYO, ITX 3. Predicate Device 510(K) number: K190769 Device Name: Bladder Scanner (Models:M2, M2-W, M1, M1-W) Manufacturer: Suzhou Lischka Medtech… | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K250331 (Astrasono Technology Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Bladder Scanner (Models: M3, M3-HD, M4, M4-HD) is B-mode pulsed-echo ultrasound device. It intended as a handheld battery-operated device. The M3, M3-HD, M4, M4-HD Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder Volume noninvasively. The M3, M3-HD, M4, M4-HD Bladder Scanner is intended to be used only by qualified medical professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201316 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201316
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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