510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881515Substantially Equivalent

Tear Volume Tests

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

K881515 is the FDA 510(k) clearance record for TEAR VOLUME TESTS, a class I device, cleared for Visionex, Inc. on under FDA product code KYD (Strip, Schirmer). FDA records list 2 510(k) clearances for Visionex, Inc., from to . As of , FDA records show no recalls naming K881515.

Clearance record

Decision date
Received
(42 days to decision)
Product code
KYD Strip, Schirmer
Regulation
21 CFR 886.1800
Device class
Class I
Review panel
Ophthalmic
Applicant
Visionex, Inc. 1206 Sargent Dr., Sunnyvale CA
Third party review
No

Clearances, product code KYD

Trailing 12 months

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

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