# K032799: Non-Contact Tonometers, Ocular Response Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Reichert, Inc.
- Decided: Jan 20, 2004 after 133 days
- Product code: HKX (Tonometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ORA is intended to measure intra-ocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma.

Source page: https://510kreport.com/device/K032799
Methodology: https://510kreport.com/methodology