510(k) · Cleared
ClearedCubescan Biocon-500 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mcube Technology Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 18, 2009 as substantially equivalent to K071217 (Verathon Incorporated, 2007) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1992. 16 later devices descend from it.
- Decided
- Jun 18, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K915436 (1992). 7 ancestors in all. 16 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 3 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 2 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- 1 generation backK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- This deviceK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK171591 CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK190769 Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019
- Descendant · 4 generations on · 2 of its ownK201316 Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K111021Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011 · cites it directly13descendants
- K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013 · 2 generations on7descendants
- K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd. · 2017 · 2 generations on4descendants
- K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)Suzhou Lischka Medtech Co., Ltd. · 2019 · 3 generations on3descendants
- K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)Suzhou Peaksonic Medical Technology Co., Ltd. · 2021 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −3 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −2 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| −1 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| 0 (this device) | K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | Mcube Technology Co., Ltd. | 2009 | — |
| +1 | K111021 | Cubescan / Biocon-700 | Mcube Technology Co., Ltd. | 2011 | — |
| +2 | K131227 | Padscan HD Series Bladder Scanner | Carenoso Technology Co., Ltd. | 2013 | — |
| +2 | K171591 | CUBEScan™ BioCon-900 (Bladder Volume Measurement System) | Mcube Technology Co., Ltd. | 2017 | — |
| +3 | K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | Suzhou Lischka Medtech Co., Ltd. | 2019 | — |
| +4 | K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | Suzhou Peaksonic Medical Technology Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K071217 | Bladderscan Bvi 9400 UltrasoundSummary page 1…onic 3. Predicate Device: Manufacturer : VERATHON INCORPORATED Device :BVI 9400 510(k) Number :K071217(Decision Date - May 17. 2007) Manufacturer :Med iwatch Ltd. Device :Multisc… | 2007 |
| * | K053325 | Mediwatch Multiscan Ultrasound System/Scanner, Model M0002 (Scanner Only); Multiscan…Summary page 1…(Decision Date - May 17. 2007) Manufacturer :Med iwatch Ltd. Device :Multiscan 510(k) Number :K053325 (Decision Date - Dec. 7. 2005) 4. Classifications Names & Citations: 21ICFR 892.1560, 1570, IYO, ITX, system, imaging,… | 2005 |
| * | — | Model M0001/M0002 Named without a submission number |
What descends from it? (16)
See all 162 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 17 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K111021 (Mcube Technology Co., Ltd., 2011) has gone furthest, with 13 descendants of its own.
- 11 other devices also cite its predicate K071217.
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. 2009, 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 BioCon-500 is a B-mode pulsed-echo ultrasound device. The BioCon-500 is intended to project ultrasound energy through the abdomen of the patient to obtain images of the bladder and to calculate the bladder volume non-invasively using these images. Contraindications for the BioCon-500 are fetal use and use on pregnant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091518: Cubescan Biocon-500 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091518
Report an extraction error
Are you the manufacturer?
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