# K241447: iCare ST500 (TA04)

- Pathway: 510(k) (Traditional)
- Applicant: Icare Finland OY
- Decided: Sep 27, 2024 after 128 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: 6 generations back to K943939 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220852: iCare IC200, Icare Finland OY (2022) Summary page 5.

## Indications for use
The iCare ST500 tonometer is a device intended to be used for the measurement of the intraocular pressure of the human eye. The iCare ST500 tonometer is intended to be used by healthcare professionals.

Source page: https://510kreport.com/device/K241447
Methodology: https://510kreport.com/methodology