510(k) · Cleared
ClearedWireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Sonostar Technologies Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 28, 2018 as substantially equivalent to K151339 (Healcerion Co., Ltd., 2015) and 2 other predicates after a 169-day review. Its family tree reaches back 11 generations to 1995. 4 later devices descend from it.
- Decided
- Feb 28, 2018
- Review
- 169 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K935595 (1995). 102 ancestors in all, the oldest K850478 (1985). 4 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 7 generations between
- 3 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 2 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 1 generation backK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- This deviceK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK211321 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C…Guangzhou Sonostar Technologies Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260111 Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK220169 SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C…Bionet Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK213488 Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd. · 2022
Show all 11 generations
- Root · 11 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 10 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 9 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 8 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 7 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 2 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 1 generation backK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- This deviceK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT…Guangzhou Sonostar Technologies Co., Ltd. · 2022 · cites it directly1descendant
- K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026 · cites it directly0descendants
- K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB…Bionet Co., Ltd. · 2022 · cites it directly0descendants
- K213488Bladder Scanner, Model Name:M5Suzhou Peaksonic Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −10 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −9 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −8 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −7 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −2 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| −1 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| 0 (this device) | K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | Guangzhou Sonostar Technologies Co., Ltd. | 2018 | — |
| +1 | K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L… | Guangzhou Sonostar Technologies Co., Ltd. | 2022 | — |
| +1 | K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | Mytech Intelligence (Shenzhen) Co., Ltd. | 2026 | — |
| +1 | K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L… | Bionet Co., Ltd. | 2022 | — |
| +1 | K213488 | Bladder Scanner, Model Name:M5 | Suzhou Peaksonic Medical Technology Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 11 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C)Summary page 8…logies Co., Ltd. 7.3 Predicate Device Information Predicate Device 1: SONON Ultrasound Imaging System (Model: SONON 300C) submitted by HEALCERION Co., Ltd. 510K Number: K151339 Predicate Device 2: Penrith Elettra Ultrasound System submitted by Penrith Corporation 510K Number: K100598 Predicate Device 3: P… | 2015 |
| * | K100598 | Penrith Elettra Ultrasound SystemSummary page 8…l: SONON 300C) submitted by HEALCERION Co., Ltd. 510K Number: K151339 Predicate Device 2: Penrith Elettra Ultrasound System submitted by Penrith Corporation 510K Number: K100598 Predicate Device 3: Palm Bladder Scanner - PBSV4.1 submitted by Mianyang Meike Electronic Equipment Co., Ltd. 510K Number: K13022… | 2010 |
| * | K130229 | Palm Bladder ScannerSummary page 8…ed by Penrith Corporation 510K Number: K100598 Predicate Device 3: Palm Bladder Scanner - PBSV4.1 submitted by Mianyang Meike Electronic Equipment Co., Ltd. 510K Number: K130229 7.4 Device Description The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) is a wireless ultrasound… | 2013 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT… | 2022 | 1 |
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | 2026 | 0 |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB… | 2022 | 0 |
| K213488 | Bladder Scanner, Model Name:M5 | 2022 | 0 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 102 ancestors have a recall of any class.
- Of its descendants, K211321 (Guangzhou Sonostar Technologies Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K151339.
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. 2018, 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 Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging…
Read the full statement (149 words)
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-C) (frequency: 3.5Hz, module: convex) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging.
The Wireless Probe Type Ultrasound Scanner (Model: UProbe-L) (frequency: 7.5Hz, module: linear) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including small organ and peripheral vessel imaging.
The Wireless Probe Type Ultrasound Scanner (Model: BProbe) is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172750
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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