# K033146: Tono-Pen Tonometer Tip Cover

- Pathway: 510(k) (Traditional)
- Applicant: Tra & Accessories
- Decided: Nov 23, 2004 after 420 days
- Product code: HKY (Tonometer, Manual)
- 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 Tono-Film Tonometer Tip Cover is intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and used in the diagnosis of glaucoma.

Source page: https://510kreport.com/device/K033146
Methodology: https://510kreport.com/methodology