510(k) · Cleared
ClearedEndoserter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocular Systems, Inc. · OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Cleared on Jan 21, 2011 after a 683-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jan 21, 2011
- Review
- 683 days
- Class
- Class I
- Product code
- OTZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK090626 EndoserterOcular Systems, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK121579 EK Delivery DeviceTdak Medical, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK203586 EndoSerter-PLCorneagen, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK102999 Trimotion InjectorKaneka Corp. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090626 | Endoserter | Ocular Systems, Inc. | 2011 | — |
| +1 | K121579 | EK Delivery Device | Tdak Medical, Inc. | 2012 | — |
| +2 | K203586 | EndoSerter-PL | Corneagen, Inc. | 2022 | — |
| +1 | K102999 | Trimotion Injector | Kaneka Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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 OTZ? 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 OTZ device
- #1 K203586 EndoSerter-PLscore 3.1 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
2 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?
- Of its descendants, K121579 (Tdak Medical, Inc., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OTZ devicesOTZ Graft Insertion Instrument For Endothelial Keratoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OTZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OTZ
Too few OTZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OTZ
No recall names OTZ since 2007.
Adverse event reports per year · OTZ
1in 2024
MAUDE reports naming product code OTZ, 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 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K090626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090626: Endoserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090626
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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