# K232302: Pocket III

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Apr 26, 2024 after 269 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 K920906 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993674: Pocket Ultrasonic Pachymeter, Quantel Medical (2000) Summary page 4.

## Indications for use
The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.

Source page: https://510kreport.com/device/K232302
Methodology: https://510kreport.com/methodology