# K052891: Horizon Epikeratome Disposable Microkeratome System

- Pathway: 510(k) (Traditional)
- Applicant: Hawken Industries
- Decided: Mar 23, 2006 after 161 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K843646 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981155: Flapmaker Disposable Microkeratome, Hawken Industries (1998) Summary page 1.
- K051486: Norwood Abbey Centurion Ses  Epikeratome, Norwood Abbey, Ltd. (2005) Summary page 1.

## Indications for use
The Horizon EpikeratomeTM is indicated when it is desired to use a single-use microkeratome system that is intended to be used solely to make anterior lamellar corneal resections of preselected thickness and diameter and for the separation of the epithelium from the cornea for subsequent surgical procedures on denuded cornea.

Source page: https://510kreport.com/device/K052891
Methodology: https://510kreport.com/methodology