510(k) · Cleared
ClearedTrimotion Injector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaneka Corp. · OTZ Graft Insertion Instrument For Endothelial Keratoplasty
Cleared on Dec 29, 2011 as substantially equivalent to K090626 (Ocular Systems, Inc., 2011) after a 447-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Dec 29, 2011
- Review
- 447 days
- Class
- Class I
- Product code
- OTZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090626 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK090626 EndoserterOcular Systems, Inc. · 2011
- This deviceK102999 Trimotion InjectorKaneka Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090626 | Endoserter | Ocular Systems, Inc. | 2011 | — |
| 0 (this device) | K102999 | Trimotion Injector | Kaneka Corp. | 2011 | — |
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 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? (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 |
|---|---|---|---|
| * | K090626 | Endoserter Cleared while this submission was under review Summary page 1…Class I reserved Predicate Device: The predicate device is the Ocular System Inc. EndoSerterTm corneal endotheliumn delivery instrument (510(k) No. K090626), cleared by the Food and Drug Administration on January 21, 2011. Device Description: The Kaneka TrimotionTM Injector is indic… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K090626.
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 Kaneka TrimotionTM Injector is indicated for insertion and placement of donor corneal tissue (diameter: < 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102999: Trimotion Injector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102999
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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