510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K871335Substantially Equivalent

Topcon Computerized Tonometer CT-10

Topcon Instrument Corporation of America, Paramus NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871335 is the FDA 510(k) clearance record for TOPCON COMPUTERIZED TONOMETER CT-10, a class II device, cleared for Topcon Instrument Corporation of America on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list one 510(k) clearance for Topcon Instrument Corporation of America. As of , FDA records show no recalls naming K871335.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Topcon Instrument Corporation of America 65 W. Century Rd., Paramus NJ
Third party review
No

Clearances, product code HKX

Trailing 12 months
1 clearance under product code HKX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260