510(k) · Cleared
ClearedU-Lite PRO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoscanner Sarl · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 11, 2024 as substantially equivalent to K201988 (Sonoscanner, 2020) after a 164-day review. Its family tree reaches back 21 generations to 1995.
- Decided
- Jan 11, 2024
- Review
- 164 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K935595 (1995). 134 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 17 generations between
- 3 generations backK143601 U-LiteSonoscanner Sarl · 2015
- 2 generations backK171164 U-Lite EXPSonoscanner · 2017
- 1 generation backK201988 T-LiteSonoscanner · 2020
- This deviceK232285 U-Lite PROSonoscanner Sarl · 2024
Show all 21 generations
- Root · 21 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 19 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 18 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 17 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 16 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 15 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 14 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 13 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 12 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 11 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 10 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 9 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 8 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 7 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 6 generations backK122114 Logiq S7 Expert, Logiq S7 ProGE Healthcare · 2012 · Recalled
- 5 generations backK131527 Logiq S8GE Healthcare · 2013
- 4 generations backK133431 VENUE 50GE Healthcare · 2013
- 3 generations backK143601 U-LiteSonoscanner Sarl · 2015
- 2 generations backK171164 U-Lite EXPSonoscanner · 2017
- 1 generation backK201988 T-LiteSonoscanner · 2020
- This deviceK232285 U-Lite PROSonoscanner Sarl · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −20 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −19 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −18 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −17 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −16 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −15 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −14 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −13 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −12 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −11 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −10 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −9 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −8 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −7 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −6 | K122114 | Logiq S7 Expert, Logiq S7 Pro | GE Healthcare | 2012 | 1 |
| −5 | K131527 | Logiq S8 | GE Healthcare | 2013 | — |
| −4 | K133431 | VENUE 50 | GE Healthcare | 2013 | — |
| −3 | K143601 | U-Lite | Sonoscanner Sarl | 2015 | — |
| −2 | K171164 | U-Lite EXP | Sonoscanner | 2017 | — |
| −1 | K201988 | T-Lite | Sonoscanner | 2020 | — |
| 0 (this device) | K232285 | U-Lite PRO | Sonoscanner Sarl | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 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 |
|---|---|---|---|
| * | K201988 | T-LiteSummary page 6…icate Devices: Manufacturer Brand Name 510(k) Number Primary Predicate Sonoscanner T Lite K201988 Reference Predicate Sonoscanner U-Lite Exp K171164 Reference Predicate Edan Instruments, Diagno… | 2020 |
| † | K171164 | U-Lite EXP | 2017 |
| † | K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3… | 2021 |
| † | K231301 | Vscan Air | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 39 of the 134 ancestors have a recall of any class.
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. 2024, 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?
U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals. It can therefore be used in different configurations, especially: - In medical offices (general practitioner's office) - In clinics & hospitals (incl. in emergency and critical care units) - In a field hospital It is used in imaging or examinations rooms. It can be used at the bedside. It is not…
Read the full statement (222 words)
U-Lite PRO is a Handheld Ultrasound system intended for use in environments where healthcare is provided by qualified and trained healthcare professionals.
It can therefore be used in different configurations, especially:
- In medical offices (general practitioner's office)
- In clinics & hospitals (incl. in emergency and critical care units)
- In a field hospital
It is used in imaging or examinations rooms.
It can be used at the bedside. It is not intended for direct use in a sterile environment.
The U-Lite PRO is not compatible with the use of the HF surgery device or in an MRI system.
U-Lite PRO is indicated for the visualization of structures and dynamic processes in the human body using ultrasound imaging and fluid flow analysis for diagnosis in the following clinical applications:
• ophthalmic
• fetal/obstetric,
• gynecological,
• abdominal,
• pediatric,
• neonatal cephalic
• adult cephalic
• small organ,
• trans-vaginal,
• trans-rectal,
• cardiac adult & pediatric
• peripheral vascular,
• urology (including prostate)
• musculoskeletal (both conventional and superficial)
Note : The application fields are dependent on the selected probes and the modes of operations.
Modes of operations include:
• B-Mode (B)
• M-Mode (M)
• Color Doppler (CD)
• Power Doppler (PD)
• Spectral Pulsed-Wave Doppler (PWD)
• Continous Wave Doppler (CWD)
• Combined :(B+M; B+CD; B+ PD; B+PWD)
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/K232285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232285: U-Lite PRO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232285
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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