510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934085Substantially Equivalent

Modification of Surgical Eyeshield Mask

American Threshold Industries, Inc., Enka NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934085 is the FDA 510(k) clearance record for MODIFICATION OF SURGICAL EYESHIELD MASK, a class I device, cleared for American Threshold Industries, Inc. on under FDA product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)). FDA records list 20 510(k) clearances for American Threshold Industries, Inc., from to . As of , FDA records show no recalls naming K934085.

Clearance record

Decision date
Received
(84 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
American Threshold Industries, Inc. 240 Sardis Rd., Enka NC
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOY, 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