510(k) · Cleared
ClearedVUMAX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonomed, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 11, 2006 after a 33-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Apr 11, 2006
- Review
- 33 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK060626 VUMAXSonomed, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK140199 VUPADSonomed, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK170761 LIGHTSonic BUBMLightmed USA, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK213070 MD-320W Ultrasound BiomicroscopeMEDA Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK183173 LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK171301 Scanmate FlexDgh Technology, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140199VUPADSonomed, Inc. · 2014 · cites it directly4descendants
- K170761LIGHTSonic BUBMLightmed USA, Inc. · 2018 · 2 generations on1descendant
- K213070MD-320W Ultrasound BiomicroscopeMEDA Co., Ltd. · 2021 · 2 generations on0descendants
- K183173LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019 · 3 generations on0descendants
- K171301Scanmate FlexDgh Technology, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060626 | VUMAX | Sonomed, Inc. | 2006 | — |
| +1 | K140199 | VUPAD | Sonomed, Inc. | 2014 | — |
| +2 | K170761 | LIGHTSonic BUBM | Lightmed USA, Inc. | 2018 | — |
| +2 | K213070 | MD-320W Ultrasound Biomicroscope | MEDA Co., Ltd. | 2021 | — |
| +3 | K183173 | LIGHTMED Ultrasound System | Lightmed USA, Inc. | 2019 | — |
| +2 | K171301 | Scanmate Flex | Dgh Technology, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | Sonomed EZ-Scan AB 5500+ Named without a submission number |
What descends from it? (7)
3 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?
- Of its descendants, K140199 (Sonomed, Inc., 2014) has gone furthest, with 4 descendants of its own.
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.
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 VuMax ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye.
The VuMax 35 MHz transducer is for use with the VuMax ultrasound.
The VuMax 50 MHz transducer is for use with the Vumax ultrasound system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060626: VUMAX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060626
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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