510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934880Substantially Equivalent

Mti Photoscreener

Medical Technology and Innovations, Inc., Cedar Falls IA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934880 is the FDA 510(k) clearance record for MTI PHOTOSCREENER, a class II device, cleared for Medical Technology and Innovations, Inc. on under FDA product code MMF (Photorefractor). FDA records list 3 510(k) clearances for Medical Technology and Innovations, Inc., from to . As of , FDA records show no recalls naming K934880.

Clearance record

Decision date
Received
(176 days to decision)
Product code
MMF Photorefractor
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Medical Technology and Innovations, Inc. 1710 Adams St., Cedar Falls IA
510(k) summary
Summary
Third party review
No

Clearances, product code MMF

Trailing 12 months

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

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