510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946226Substantially Equivalent

Custom Ocular Prosthesis

Frank Tanaka, Ocularist, Inc., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K946226 is the FDA 510(k) clearance record for CUSTOM OCULAR PROSTHESIS, a class I device, cleared for Frank Tanaka, Ocularist, Inc. on under FDA product code HQH (Eye, Artificial, Non-Custom). FDA records list one 510(k) clearance for Frank Tanaka, Ocularist, Inc. As of , FDA records show no recalls naming K946226.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HQH Eye, Artificial, Non-Custom
Regulation
21 CFR 886.3200
Device class
Class I
Review panel
Ophthalmic
Applicant
Frank Tanaka, Ocularist, Inc. 3000 E. Fletcher Ave.,, Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code HQH

Trailing 12 months

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

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