510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800459Substantially Equivalent

Barium Sulfate, Usp in Suspension

Central Pharmaceuticals, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800459 is the FDA 510(k) clearance record for BARIUM SULFATE, USP IN SUSPENSION, cleared for Central Pharmaceuticals, Inc. on under FDA product code KTA (Medium, Contrast, Radiologic). FDA records list one 510(k) clearance for Central Pharmaceuticals, Inc. As of , FDA records show no recalls naming K800459.

Clearance record

Decision date
Received
(91 days to decision)
Product code
KTA Medium, Contrast, Radiologic
Device class
Unclassified
Review panel
Unknown
Applicant
Central Pharmaceuticals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KTA

Trailing 12 months

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

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