# K121579: EK Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Tdak Medical, Inc.
- Decided: Oct 3, 2012 after 126 days
- Product code: OTZ (Graft Insertion Instrument For Endothelial Keratoplasty)
- Device class: 1
- Regulation: 21 CFR 886.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090626 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090626: Endoserter, Ocular Systems, Inc. (2011) Summary page 2.

## Most influential descendants
- K203586: EndoSerter-PL (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K121579
Methodology: https://510kreport.com/methodology