# K063472: Ultrasonic Biometer/ Pachymeter for Ophthalmology, Model Odm 2100, 2200

- Pathway: 510(k) (Traditional)
- Applicant: Meda, Ltd.
- Decided: Jan 31, 2007 after 77 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 K913067 (1992). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043287: Palmscan AP2000; Palmscan A2000; Palmscan P2000, Micromedical Devices, Inc. (2004) Summary page 2.

## Most influential descendants
- K121243: Ultrasonic Biometer for Ophthalmology Ultrasonic Pachymeter (2013), 1 descendant of its own
- K152318: MD-2300S Ultrasonic A/B Scanner for Ophthalmology (2015), 0 descendants of its own

## Indications for use
Ultrasound Imaging of the Eye Axial biometric parameter measurement of the Eye

Source page: https://510kreport.com/device/K063472
Methodology: https://510kreport.com/methodology