# K063873: Icare Tonometer TA01I

- Pathway: 510(k) (Traditional)
- Applicant: Tiolat OY
- Decided: May 23, 2007 after 145 days
- Product code: HKY (Tonometer, Manual)
- 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 K943939 (1995). 6 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981432: Goldman Manual Tonometer, Golden Vision, Inc. (1999) Summary page 2.
- K053430: Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover, Medtronic Xomed, Inc. (2006) Summary page 2.
- K032967: Pascal Dynamic Contour Tonometer, Smt Swiss Microtechnology AG (2003) Summary page 2.
- K021937: TGDC-01 Pra, Truevision Instruments (2002) Summary page 2.

## Most influential descendants
- K153694: Icare ic100 (2016), 4 descendants of its own
- K190316: Icare ic200 (2020), 2 descendants of its own
- K163343: Icare HOME tonometer (2017), 2 descendants of its own
- K220852: iCare IC200 (2022), 1 descendant of its own
- K200966: Icare HOME Tonometer (2020), 1 descendant of its own

## Indications for use
The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.

Source page: https://510kreport.com/device/K063873
Methodology: https://510kreport.com/methodology