510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991284Substantially Equivalent

Anterior Eye-Segment Analysis System

Nidek, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991284 is the FDA 510(k) clearance record for ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM, a class II device, cleared for Nidek, Inc. on under FDA product code MXK (Device, Analysis, Anterior Segment). FDA records list 21 510(k) clearances for Nidek, Inc., from to . As of , FDA records show no recalls naming K991284.

Clearance record

Decision date
Received
(113 days to decision)
Product code
MXK Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Nidek, Inc. 47651 Westinghouse Dr., Fremont CA
510(k) summary
Summary
Third party review
No

Clearances, product code MXK

Trailing 12 months
2 clearances under product code MXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260