510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940430Substantially Equivalent

Sedratrol

Medical Specialties Intl., Inc., South Plainfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940430 is the FDA 510(k) clearance record for SEDRATROL, a class II device, cleared for Medical Specialties Intl., Inc. on under FDA product code GJR (Control, Red-Cell). FDA records list 5 510(k) clearances for Medical Specialties Intl., Inc., from to . As of , FDA records show no recalls naming K940430.

Clearance record

Decision date
Received
(371 days to decision)
Product code
GJR Control, Red-Cell
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Medical Specialties Intl., Inc. 3610 Kennedy Rd., South Plainfield NJ
510(k) summary
Summary
Third party review
No

Clearances, product code GJR

Trailing 12 months

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

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