510(k) · Cleared
ClearedPadscan HD Series Bladder Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carenoso Technology Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 12, 2013 as substantially equivalent to K111021 (Mcube Technology Co., Ltd., 2011) after a 73-day review. Its family tree reaches back 6 generations to 1992. 7 later devices descend from it.
- Decided
- Jul 12, 2013
- Review
- 73 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915436 (1992). 9 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 5 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 4 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- 3 generations backK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- 2 generations backK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
- 1 generation backK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
- This deviceK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK190769 Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK201316 Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK250331 Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK230986 Bladder ScannerAvantsonic Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223448 Bladder Scanner Model: BVT02Xuzhou Kaixin Electronic Instrument Co., Ltd. · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019 · cites it directly3descendants
- K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 2021 · 2 generations on2descendants
- K250331Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd. · 2025 · 3 generations on0descendants
- K230986Bladder ScannerAvantsonic Technology Co., Ltd. · 2023 · 3 generations on0descendants
- K223448Bladder Scanner Model: BVT02Xuzhou Kaixin Electronic Instrument Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −5 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −4 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| −3 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| −2 | K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | Mcube Technology Co., Ltd. | 2009 | — |
| −1 | K111021 | Cubescan / Biocon-700 | Mcube Technology Co., Ltd. | 2011 | — |
| 0 (this device) | 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 | — |
| +2 | K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021 | — |
| +3 | K250331 | Astrasono A3Pro Bladder Scanner (A3Pro) | Astrasono Technology Co., Ltd. | 2025 | — |
| +3 | K230986 | Bladder Scanner | Avantsonic Technology Co., Ltd. | 2023 | — |
| +1 | K223448 | Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K111021 | Cubescan / Biocon-700Summary page 1…CFR 892.1570 Diagnostic Ultrasonic Transducer (90-ITX) 5. Predicate Device Manufacturer: Mcube Technology Co., Ltd. Device: CUBEscan BioCon-700 51 0(k) Number: K1 11021 (Decision Date-April 27, 2011) 510(k) Summary 6. Intended Use The PadScan HO series Bladder Scanner projects… | 2011 |
What descends from it? (7)
4 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 21 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K190769 (Suzhou Lischka Medtech Co., Ltd., 2019) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K111021.
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. 2013, 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 PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable battery-operated device. The PadScan HD series 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 PadScan HD series 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/K131227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131227: Padscan HD Series Bladder Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131227
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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