510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904961Substantially Equivalent

Artificial Scleral Shell

Midwest Eye Laboratories, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904961 is the FDA 510(k) clearance record for ARTIFICIAL SCLERAL SHELL, a class II device, cleared for Midwest Eye Laboratories, Inc. on under FDA product code HQT (Shell, Scleral). FDA records list 2 510(k) clearances for Midwest Eye Laboratories, Inc. As of , FDA records show no recalls naming K904961.

Clearance record

Decision date
Received
(298 days to decision)
Product code
HQT Shell, Scleral
Regulation
21 CFR 886.3800
Device class
Class II
Review panel
Ophthalmic
Applicant
Midwest Eye Laboratories, Inc. 9975 Lyndale Ave. So., Minneapolis MN
Third party review
No

Clearances, product code HQT

Trailing 12 months

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

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