510(k) · Cleared

Cleared

EK Delivery Device

K121579510(k) TraditionalCleared Oct 3, 2012126-day reviewClass I21 CFR 886.4300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tdak Medical, Inc. · OTZ Graft Insertion Instrument For Endothelial Keratoplasty

Cleared on Oct 3, 2012 as substantially equivalent to K090626 (Ocular Systems, Inc., 2011) after a 126-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.

Decided: Oct 3, 2012
Review: 126 days
Class: Class I
Product code: OTZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K090626 (2011). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK090626 EndoserterOcular Systems, Inc. · 2011
This deviceK121579 EK Delivery DeviceTdak Medical, Inc. · 2012
Descendant · cites it directly · 0 of its ownK203586 EndoSerter-PLCorneagen, Inc. · 2022

Most influential descendants

Showing 1 of 1 · See all

K203586EndoSerter-PLCorneagen, Inc. · 2022 · cites it directly0descendants

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)	K121579	EK Delivery Device	Tdak Medical, Inc.	2012	—
+1	K203586	EndoSerter-PL	Corneagen, Inc.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K121579, 2011–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K090626	Endoserter Summary page 2 …K1297 510(k) Number Trade or Proprietary or Model Name Manufacturer K090626 EndoertermTI Ocular Systems, Inc. The Endothelial Keratoplasty Injector is a single-use, dis…	Ocular Systems, Inc.	2011	—

Also cleared against K090626: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K203586	EndoSerter-PL	Corneagen, Inc.	2022	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, K203586 (Corneagen, Inc., 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K090626.

How does its category compare?

All OTZ devices

OTZ Graft Insertion Instrument For Endothelial Keratoplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · OTZ

1in 2022

2007high 2 (2011) · low 0 (2007)2026

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

2007high 1 (2024) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	2	—	0
2012	2	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:

An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100–220 μm of thickness into the anterior chamber of the eye during endothelial keratoplasty.

For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of 8.5 mm.

For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121579: EK Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121579

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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