510(k) · Cleared
ClearedIV-eye
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novarix Limited · KZA Device, Vein Location, Liquid Crystal
Cleared on Feb 24, 2016 as substantially equivalent to K042679 (Infrared Imaging Systems, Inc., 2004) and 1 other predicate after a 212-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Feb 24, 2016
- Review
- 212 days
- Class
- Class I
- Product code
- KZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K042679 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK042679 IR ViewerInfrared Imaging Systems, Inc. · 2004
- This deviceK152088 IV-eyeNovarix Limited · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042679 | IR Viewer | Infrared Imaging Systems, Inc. | 2004 | — |
| 0 (this device) | K152088 | IV-eye | Novarix Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K042679 | IR ViewerSummary page 5…Product Code Regulation Sponsor Infrared Imaging IR Viewer K042679 KZA 21 CFR 880.6970 System… | 2004 |
| * | K101838 | VTS1000Summary page 5…K042679 KZA 21 CFR 880.6970 System VTS1000 (Veinsite) K101838 KZA 21 CFR 880.6970 VueTek Scientific 6. Device Description The IV-eye is a hand-held, batter… | 2011 |
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?
- None of the 2 ancestors has a recall.
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. 2016, 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 IV-eye is a hand-held, non-invasive imaging device that assists medical personnel, trained in vascular access procedure, to identify and locate suitable peripheral veins for the purposes of cannulation and venipuncture.
The IV-eye should only be used in conjunction with standard techniques of visualization and palpation in assessing and locating veins.
The IV-eye is intended only for skin contact via a disposable single use cover.
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/K152088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152088: IV-eye.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152088
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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