510(k) · Cleared
ClearedCUBEScan™ BioCon-900 (Bladder Volume Measurement 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 22, 2017 as substantially equivalent to K111021 (Mcube Technology Co., Ltd., 2011) after a 22-day review. Its family tree reaches back 6 generations to 1992. 4 later devices descend from it.
- Decided
- Jun 22, 2017
- Review
- 22 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. 4 later devices descend from it, 2 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 deviceK171591 CUBEScan™ BioCon-900 (Bladder Volume Measurement System)Mcube Technology Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK200548 CUBEScan BioCon-1100Mcube Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK260313 MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK201995 CUBEScan BioCon-1100Mcube Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK200749 CUBEScan BioCon-900SMcube Technology Co., Ltd. · 2020
Most influential descendants
Showing 4 of 4 · See all- K200548CUBEScan BioCon-1100Mcube Technology Co., Ltd. · 2020 · cites it directly2descendants
- K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026 · 2 generations on0descendants
- K201995CUBEScan BioCon-1100Mcube Technology Co., Ltd. · 2020 · 2 generations on0descendants
- K200749CUBEScan BioCon-900SMcube Technology Co., Ltd. · 2020 · 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) | K171591 | CUBEScan™ BioCon-900 (Bladder Volume Measurement System) | Mcube Technology Co., Ltd. | 2017 | — |
| +1 | K200548 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | 2020 | — |
| +2 | K260313 | MD-6000S Bladder Scanner | MEDA Co., Ltd. | 2026 | — |
| +2 | K201995 | CUBEScan BioCon-1100 | Mcube Technology Co., Ltd. | 2020 | — |
| +1 | K200749 | CUBEScan BioCon-900S | Mcube Technology Co., Ltd. | 2020 | — |
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 |
|---|---|---|
| 2020 | 3 | 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? (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 4…cardiac Other (specify) Peripheral Peripheral vessel Vessel Other N = new indication; P = previously cleared by FDA in K111021; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmon… | 2011 |
What descends from it? (4)
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 25 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K200548 (Mcube Technology Co., Ltd., 2020) has gone furthest, with 2 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. 2017, 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?
BioCon-900 is a B-mode pulsed-echo ultrasound device. The BioCon-900 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. BioCon-900 is intended to be used by a qualified medical professional to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-900 are fetal use and use on pregnant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171591: CUBEScan™ BioCon-900 (Bladder Volume Measurement System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171591
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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