# K190316: Icare ic200

- Pathway: 510(k) (Traditional)
- Applicant: Icare Finland OY
- Decided: Jan 14, 2020 after 335 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: 4 generations back to K943939 (1995). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153694: Icare ic100, Icare Finland OY (2016) Summary page 4.

## Most influential descendants
- K220852: iCare IC200 (2022), 1 descendant of its own
- K241447: iCare ST500 (TA04) (2024), 0 descendants of its own

## Indications for use
The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.

Source page: https://510kreport.com/device/K190316
Methodology: https://510kreport.com/methodology