# K993674: Pocket Ultrasonic Pachymeter

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Jul 13, 2000 after 255 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: 1 generation back to K920906 (1992). 2 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924311: Sonomed 4000P Ultrasonic Pachymeter, Sonomed, Inc. (1992) Summary page 1.
- K920906: DGH-500 Pachymeter, Dgh Technology, Inc. (1992) Summary page 1.

## Most influential descendants
- K094038: Compact Touch (2010), 3 descendants of its own
- K180265: COMPACT TOUCH Ophthalmic Ultrasound System (2018), 1 descendant of its own
- K232302: Pocket III (2024), 0 descendants of its own
- K213254: Axialis Ophthalmic Ultrasound System (2021), 0 descendants of its own
- K102027: Axis Nano Opthalmic Biometer Ultrasound System (2010), 0 descendants of its own

## Indications for use
The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be used for the measurement of corneal thickness by ultrasonic means, which is required for some types of corneal surgery.

Source page: https://510kreport.com/device/K993674
Methodology: https://510kreport.com/methodology