510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964289Substantially Equivalent

Eye Fixation Speculum

Eyefix, Inc., Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964289 is the FDA 510(k) clearance record for EYE FIXATION SPECULUM, a class I device, cleared for Eyefix, Inc. on under FDA product code HNC (Specula, Ophthalmic). FDA records list one 510(k) clearance for Eyefix, Inc. As of , FDA records show no recalls naming K964289.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HNC Specula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Eyefix, Inc. 12300 Twinbrook Pkwy., Rockville MD
510(k) summary
Summary
Third party review
No

Clearances, product code HNC

Trailing 12 months

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

FDA records show no clearances under product code HNC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HNC, 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