# K040373: Kerato Analyzer (Eka)

- Pathway: 510(k) (Traditional)
- Applicant: Konan Medical, Inc.
- Decided: Mar 19, 2004 after 31 days
- Product code: NQE (Microscope, Specular)
- Device class: 2
- Regulation: 21 CFR 886.1850
- 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 K950091 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950091: Konan Noncon Robo Specular Microscope, Models SP 6000 and SP 8000, Konan Medical, Inc. (1995) Summary page 1.
- K994340: Clinical Specular Microscope, Model Hai CL-1000XYZ, Hai Laboratories, Inc. (2000) Summary page 1.

## Indications for use
The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.

Source page: https://510kreport.com/device/K040373
Methodology: https://510kreport.com/methodology