510(k) · Cleared
ClearedFlents Plastic Eye Wash Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apothecary Products, Inc. · LXQ Cup, Eye
Cleared on Jul 9, 2014 as substantially equivalent to K051414 (Tollot Pty.Ltd.(Aaxis Pacific), 2005) after a 141-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Jul 9, 2014
- Review
- 141 days
- Class
- Class U
- Product code
- LXQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051414 (2005). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K151575Dynarex Eye CupsDynarex Corporation · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051414 | Eye Cup, Sterile 1 and Non Sterile | Tollot Pty.Ltd.(Aaxis Pacific) | 2005 | — |
| 0 (this device) | K140409 | Flents Plastic Eye Wash Cup | Apothecary Products, Inc. | 2014 | — |
| +1 | K151575 | Dynarex Eye Cups | Dynarex Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K051414 | Eye Cup, Sterile 1 and Non SterileSummary page 1…sual name: Eye Cup Classification: Ophthalmic - Unclassified - ike-Arnendment Product Code: LXQ Predicate Device information: K051414 Device Description:. The Rents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plasti… | 2005 |
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 |
|---|---|---|---|
| K151575 | Dynarex Eye Cups | 2015 | 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?
- Its one ancestor has no recall.
- Of its descendants, K151575 (Dynarex Corporation, 2015) has gone furthest, with 0 descendants 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. 2014, this device’s year, is highlighted.
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 Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140409: Flents Plastic Eye Wash Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140409
Report an extraction error
Are you the manufacturer?
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