510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944226Substantially Equivalent

Msi Procedure Kit

Msi, Inc., Tarpon Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944226 is the FDA 510(k) clearance record for MSI PROCEDURE KIT, a class II device, cleared for Msi, Inc. on under FDA product code DOX (Fluorometer, Lead (Dedicated Instruments)). FDA records list 2 510(k) clearances for Msi, Inc., from to . As of , FDA records show no recalls naming K944226.

Clearance record

Decision date
Received
(295 days to decision)
Product code
DOX Fluorometer, Lead (Dedicated Instruments)
Regulation
21 CFR 862.3550
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Msi, Inc. 615 Jasmine Ave. N., Tarpon Springs FL
510(k) summary
Statement
Third party review
No

Clearances, product code DOX

Trailing 12 months

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

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