# K030610: Pod Pac-20M

- Pathway: 510(k) (Traditional)
- Applicant: Portable Ophthalmic Devices, Inc.
- Decided: Mar 21, 2003 after 23 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 1.

## Indications for use
To measure thickness of the cornea in the human eye using ultrasound energy.

Source page: https://510kreport.com/device/K030610
Methodology: https://510kreport.com/methodology