# K153694: Icare ic100

- Pathway: 510(k) (Traditional)
- Applicant: Icare Finland OY
- Decided: Apr 19, 2016 after 118 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: 3 generations back to K943939 (1995). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063873: Icare Tonometer TA01I, Tiolat OY (2007) Summary page 5.

## Most influential descendants
- K190316: Icare ic200 (2020), 2 descendants of its own
- K220852: iCare IC200 (2022), 1 descendant of its own
- K241447: iCare ST500 (TA04) (2024), 0 descendants of its own
- K233516: Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) (2024), 0 descendants of its own

## Indications for use
The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

Source page: https://510kreport.com/device/K153694
Methodology: https://510kreport.com/methodology