# K083377: Accupen

- Pathway: 510(k) (Traditional)
- Applicant: Accutome Ultrasound, Inc.
- Decided: Jul 27, 2009 after 255 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 indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

Source page: https://510kreport.com/device/K083377
Methodology: https://510kreport.com/methodology