# K050552: Pachpen Pachymeter, Model 24-5100

- Pathway: 510(k) (Traditional)
- Applicant: Accutome, Inc.
- Decided: Mar 28, 2005 after 25 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K810660 (1981). 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)
- K042752: Accupach V, Accutome Ultrasound, Inc. (2004) Summary page 4.

## Indications for use
The instrument is used for measuring the corneal thickness of the eye.

Source page: https://510kreport.com/device/K050552
Methodology: https://510kreport.com/methodology