510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990869Substantially Equivalent

Leica At550

Leica Microsystems, Inc., Depew NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990869 is the FDA 510(k) clearance record for LEICA AT550, a class II device, cleared for Leica Microsystems, Inc. on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list 2 510(k) clearances for Leica Microsystems, Inc., from to . As of , FDA records show no recalls naming K990869.

Clearance record

Decision date
Received
(83 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Leica Microsystems, Inc. 3374 Walden Ave., Depew NY
510(k) summary
Statement
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