510(k) · Cleared
ClearedVUPAD
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 1, 2014 as substantially equivalent to K040668 (Sonomed, Inc., 2004) and 1 other predicate after a 64-day review. Its family tree reaches back 2 generations to 1985. 4 later devices descend from it.
- Decided
- Apr 1, 2014
- Review
- 64 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K843696 (1985). 4 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK843696 Ophthalmic a-Scan a-2000 SonomeSonomed Technology, Inc. · 1985
- 1 generation backK040668 E-Z Scan AB5500+Sonomed, Inc. · 2004
- This deviceK140199 VUPADSonomed, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK170761 LIGHTSonic BUBMLightmed USA, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK213070 MD-320W Ultrasound BiomicroscopeMEDA Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK183173 LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK171301 Scanmate FlexDgh Technology, Inc. · 2017
Most influential descendants
Showing 4 of 4 · See all- K170761LIGHTSonic BUBMLightmed USA, Inc. · 2018 · cites it directly1descendant
- K213070MD-320W Ultrasound BiomicroscopeMEDA Co., Ltd. · 2021 · cites it directly0descendants
- K183173LIGHTMED Ultrasound SystemLightmed USA, Inc. · 2019 · 2 generations on0descendants
- K171301Scanmate FlexDgh Technology, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K843696 | Ophthalmic a-Scan a-2000 Sonome | Sonomed Technology, Inc. | 1985 | — |
| −1 | K040668 | E-Z Scan AB5500+ | Sonomed, Inc. | 2004 | — |
| 0 (this device) | K140199 | VUPAD | Sonomed, Inc. | 2014 | — |
| +1 | K170761 | LIGHTSonic BUBM | Lightmed USA, Inc. | 2018 | — |
| +1 | K213070 | MD-320W Ultrasound Biomicroscope | MEDA Co., Ltd. | 2021 | — |
| +2 | K183173 | LIGHTMED Ultrasound System | Lightmed USA, Inc. | 2019 | — |
| +1 | K171301 | Scanmate Flex | Dgh Technology, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K040668 | E-Z Scan AB5500+Summary page 1…maging, pulsed echo, ultrasonic 3. Predicate Devices: Manufacturer: Sonomed, Inc. Device: E-Z Scan 5500+ A-Scan / B-Scan System 510(k) Number: K040668 Manufacturer: Sonomed, Inc. Device: VuMax System 510(k) Number: K060626 4. Classificati… | 2004 |
| * | K060626 | VUMAXSummary page 1…E-Z Scan 5500+ A-Scan / B-Scan System 510(k) Number: K040668 Manufacturer: Sonomed, Inc. Device: VuMax System 510(k) Number: K060626 4. Classification Names & Citations: Classification: Class 2 Classification Code: 21CFR 892.1560, 1… | 2006 |
What descends from it? (4)
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?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 19.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K170761 (Lightmed USA, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K040668.
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. 2014, 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 VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the…
Read the full statement (225 words)
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140199: VUPAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140199
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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