# K211355: iCare HOME2

- Pathway: 510(k) (Traditional)
- Applicant: Icare Finland OY
- Decided: Jan 25, 2022 after 267 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: 5 generations back to K943939 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200966: Icare HOME Tonometer, Icare Finland OY (2020) Summary page 4.

## Indications for use
The iCare HOME2 tonometer is a prescription device intended as an adjunct to the routine clinical monitoring of intraocular pressure (IOP) of adult patients.

Source page: https://510kreport.com/device/K211355
Methodology: https://510kreport.com/methodology