510(k) · Cleared
ClearedEye Cup, Sterile 1 and Non Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tollot Pty.Ltd.(Aaxis Pacific) · LXQ Cup, Eye
Cleared on Jun 16, 2005 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Jun 16, 2005
- Review
- 16 days
- Class
- Class U
- Product code
- LXQ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051414 | Eye Cup, Sterile 1 and Non Sterile | Tollot Pty.Ltd.(Aaxis Pacific) | 2005 | — |
| +1 | K140409 | Flents Plastic Eye Wash Cup | Apothecary Products, Inc. | 2014 | — |
| +2 | K151575 | Dynarex Eye Cups | Dynarex Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXQ? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140409 | Flents Plastic Eye Wash Cup | 2014 | 1 |
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, K140409 (Apothecary Products, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LXQ devicesLXQ Cup, Eye: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXQ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LXQ
Too few LXQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LXQ
No recall names LXQ since 2007.
Adverse event reports per year · LXQ
No MAUDE report names LXQ since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Eye Cup Sterile l's and the Eye Cup Non Sterile are each a cup that holds liquids, such as eye wash solution, used to flush out the eye.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051414: Eye Cup, Sterile 1 and Non Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051414
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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