510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K913230Substantially Equivalent

Unidirectional Occluder

Welch Allyn Inc, Skaneateles Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913230 is the FDA 510(k) clearance record for UNIDIRECTIONAL OCCLUDER, a class I device, cleared for Welch Allyn, Inc. on under FDA product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)). FDA records list 112 510(k) clearances for Welch Allyn, Inc., from to . As of , FDA records show no recalls naming K913230.

Clearance record

Decision date
Received
(72 days to decision)
Product code
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Regulation
21 CFR 886.4750
Device class
Class I
Review panel
Ophthalmic
Applicant
Welch Allyn, Inc. 4341 State St. Rd., Skaneateles Falls NY
510(k) summary
Statement
Third party review
No

Clearances, product code HOY

Trailing 12 months

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

FDA records show no clearances under product code HOY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260