510(k) · Cleared
ClearedVTS1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vuetek Scientific, LLC · KZA Device, Vein Location, Liquid Crystal
Cleared on Feb 18, 2011 after a 232-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 18, 2011
- Review
- 232 days
- Class
- Class I
- Product code
- KZA
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK101838 VTS1000Vuetek Scientific, LLC · 2011
- Descendant · cites it directly · 0 of its ownK152088 IV-eyeNovarix Limited · 2016
Most influential descendants
Showing 1 of 1 · See all- K152088IV-eyeNovarix Limited · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101838 | VTS1000 | Vuetek Scientific, LLC | 2011 | — |
| +1 | K152088 | IV-eye | Novarix Limited | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 KZA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Vustik® (Vustik, Inc.) Named without a submission number | |
| * | — | Head Mounted Display (Vista Medical) Named without a submission number |
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 |
|---|---|---|---|
| K152088 | IV-eye | 2016 | 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?
- Of its descendants, K152088 (Novarix Limited, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KZA devicesKZA Device, Vein Location, Liquid Crystal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KZA
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KZA
Too few KZA 510(k)s in any year since 2007 to give a median.
Recalls per year · KZA
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZA
3in 2024
MAUDE reports naming product code KZA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 2 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use in procedures requiring vascular or peripheral vessel access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101838: VTS1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101838
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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