510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K781363Substantially Equivalent

Cast Shoe

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

K781363 is the FDA 510(k) clearance record for CAST SHOE, a class I device, cleared for Cutler Biomedical on under FDA product code IPG (Shoe, Cast). FDA records list one 510(k) clearance for Cutler Biomedical. As of , FDA records show no recalls naming K781363.

Clearance record

Decision date
Received
(7 days to decision)
Product code
IPG Shoe, Cast
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Applicant
Cutler Biomedical 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IPG

Trailing 12 months

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

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