# K163343: Icare HOME tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Icare Finland OY
- Decided: Mar 21, 2017 after 112 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.
2 later devices descend from it; 1 cites it directly.
0 of 10 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 4.
- K981432: Goldman Manual Tonometer, Golden Vision, Inc. (1999) Summary page 4.

## Most influential descendants
- K200966: Icare HOME Tonometer (2020), 1 descendant of its own
- K211355: iCare HOME2 (2022), 0 descendants of its own

## Indications for use
The Icare HOME 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/K163343
Methodology: https://510kreport.com/methodology