# K132549: Accutip Cover

- Pathway: 510(k) (Traditional)
- Applicant: Accutome, Inc.
- Decided: Apr 23, 2014 after 252 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
Longest line of descent: 1 generation back to K882750 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882750: Ocu-Film Tip Cover, Oculab, Inc. (1988) Summary page 1.

## Indications for use
An AccuTip Cover is applied over the tip of a handheld tononieter prior to performing tonometry. The tip cover is used for protection of the patient's eye and the instrument tip.

Source page: https://510kreport.com/device/K132549
Methodology: https://510kreport.com/methodology