510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190316Substantially Equivalent

Icare ic200

Icare Finland Oy, Vantaa, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190316 is the FDA 510(k) clearance record for Icare ic200, a class II device, cleared for Icare Finland OY on under FDA product code HKY (Tonometer, Manual). FDA records list 7 510(k) clearances for Icare Finland OY, from to . As of , FDA records show no recalls naming K190316.

Clearance record

Decision date
Received
(335 days to decision)
Product code
HKY Tonometer, Manual
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Icare Finland OY Ayritie 22, Vantaa, FI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HKY

Trailing 12 months

FDA records hold no clearances under product code HKY in the trailing twelve months.

FDA records show no clearances under product code HKY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HKY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260