510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830650Substantially Equivalent

Support Products Example Proset Cast

Isopedix Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830650 is the FDA 510(k) clearance record for SUPPORT PRODUCTS EXAMPLE PROSET CAST, a class I device, cleared for Isopedix Corp. on under FDA product code ITG (Bandage, Cast). FDA records list one 510(k) clearance for Isopedix Corp. As of , FDA records show no recalls naming K830650.

Clearance record

Decision date
Received
(126 days to decision)
Product code
ITG Bandage, Cast
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Applicant
Isopedix Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ITG

Trailing 12 months

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

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