# K042099: Tonopach Ultrasonic Tonometer/Pachymeter Model P-201 (the Tonopach)

- Pathway: 510(k) (Traditional)
- Applicant: Retinapharma Technologies, Inc.
- Decided: Dec 10, 2004 after 128 days
- Product code: HKX (Tonometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1930
- 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852774: Oculab Tonopen, Oculab, Inc. (1985) Summary page 2.
- K993674: Pocket Ultrasonic Pachymeter, Quantel Medical (2000) Summary page 2.
- K020876: Echoscan, Model US-1800, Nidek, Inc. (2002) Summary page 2.

## Indications for use
The TonoPach Ultrasonic Tonometer/Pachymeter Model P-201 is a diagnostic instrument that is intended for use in the measurement of both intraocular pressure and comeal thickness. It is intended for use during or following surgery and as a screening, monitoring or diagnostic aid in patients with normal, disease-induced or surgically altered anatomy, or in glaucoma suspects under current therapeutic guidelines.

Source page: https://510kreport.com/device/K042099
Methodology: https://510kreport.com/methodology