510(k) · Cleared
ClearedKOLO Evolution XHD Series Ultrasound Diagnostic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kolo Medical (Suzhou) Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 12, 2022 as substantially equivalent to K190476 (FUJIFILM Sonosite, Inc., 2019) after a 104-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Sep 12, 2022
- Review
- 104 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062571 (2006). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK062571 Longport Episcan, Model-I-200Longport, Inc. · 2006
- 2 generations backK160674 Fujifilm Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2016
- 1 generation backK190476 FUJIFILM Sonosite Vevo MD Imaging SystemFUJIFILM Sonosite, Inc. · 2019
- This deviceK221568 KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062571 | Longport Episcan, Model-I-200 | Longport, Inc. | 2006 | — |
| −2 | K160674 | Fujifilm Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2016 | — |
| −1 | K190476 | FUJIFILM Sonosite Vevo MD Imaging System | FUJIFILM Sonosite, Inc. | 2019 | — |
| 0 (this device) | K221568 | KOLO Evolution XHD Series Ultrasound Diagnostic System | Kolo Medical (Suzhou) Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K190476 | FUJIFILM Sonosite Vevo MD Imaging SystemSummary page 4…YO Device Class: Class II Review Panel: Radiology Submitter/510(k) Holder: FUJIFILM SonoSite, Inc. Clearance: K190476 (cleared March 15, 2019) 510(k) Premarket Notification Submission… | 2019 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K190476.
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 Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment. The systems support the following clinical applications: The Evolution XHD Series Diagnostic Ultrasound System is…
Read the full statement (113 words)
The Evolution XHD Series Ultrasound Diagnostic System is a high frequency general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.
The systems support the following clinical applications:
The Evolution XHD Series Diagnostic Ultrasound System is applicable for adult and pediatric. It is intended for use in Pediatric, Small parts (breast, thyroid, testicles, prostate), Peripheral vessel, Dermatological, Musculoskeletal (conventional), Musculoskeletal (superficial).
Modes of operation include: B Mode, Color Doppler, Power Doppler, PW Doppler, Combined modes: B+Color Doppler, B+Power Doppler, B+PW Doppler.
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/K221568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221568: KOLO Evolution XHD Series Ultrasound Diagnostic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221568
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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