510(k) · Cleared
ClearedWireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Sonostar Technologies Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 13, 2022 as substantially equivalent to K172750 (Guangzhou Sonostar Technologies Co., Ltd., 2018) after a 531-day review. Its family tree reaches back 12 generations to 1995. 1 later device descends from it.
- Decided
- Oct 13, 2022
- Review
- 531 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K935595 (1995). 103 ancestors in all, the oldest K850478 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 8 generations between
- 3 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 2 generations backK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- 1 generation backK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
- This deviceK211321 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
Show all 12 generations
- Root · 12 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 11 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 10 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 9 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 8 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 7 generations backK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 6 generations backK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- 3 generations backK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- 2 generations backK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- 1 generation backK172750 Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L…Guangzhou Sonostar Technologies Co., Ltd. · 2018
- This deviceK211321 Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C…Guangzhou Sonostar Technologies Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K260111Palmtop Ultrasound Diagnostic System (MT10P/MT10)Mytech Intelligence (Shenzhen) Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −11 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −10 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −9 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −8 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −7 | K051139 | Acuson Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −6 | K052410 | Acuson Sequoia Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| −3 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| −2 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| −1 | K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | Guangzhou Sonostar Technologies Co., Ltd. | 2018 | — |
| 0 (this device) | 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 | — |
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 |
|---|---|---|
| 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)Summary page 5…Primary predicate device: Wireless Probe Type Ultrasound Scanner (Model: UProbe-C; UProbe-L; BProbe) submitted by Guangzhou Sonostar Technologies Co., Ltd. 510K Number: K172750 Reference Device: Vscan Air submitted by GE VINGMED ULTRASOUND AS (9900 Innovation Drive, wauwatosa, WI 53226) 510K Number: K202… | 2018 |
| † | K202035 | Vscan Air | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260111 | Palmtop Ultrasound Diagnostic System (MT10P/MT10) | 2026 | 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 27 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 103 ancestors have a recall of any class.
- Of its descendants, K260111 (Mytech Intelligence (Shenzhen) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K172750.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 part of this device that is intended to contact with the patient is the probe head. Modes of operation: • Pulsed-echo ultrasound • Mode B (2D) scan •…
Read the full statement (128 words)
The Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) 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 part of this device that is intended to contact with the patient is the probe head.
Modes of operation:
• Pulsed-echo ultrasound
• Mode B (2D) scan
• Mode BM scan
• Doppler mode (COLOR)
• Energy Doppler mode (PDI)
• Pulse Doppler (PW)
Operator qualifications: The operator should be capable to understand the Instructions for Use; The operator must be an appropriately-trained healthcare professional or used under the supervision of the authority of a physician.
Device use settings: hospital or home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211321: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211321
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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