510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831226Substantially Equivalent

Medical Products Foam Double Scrub #450

Ballard Medical Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831226 is the FDA 510(k) clearance record for MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450, a class I device, cleared for Ballard Medical Products on under FDA product code GEC (Brush, Scrub, Operating-Room). FDA records list 26 510(k) clearances for Ballard Medical Products, from to . As of , FDA records show no recalls naming K831226.

Clearance record

Decision date
Received
(31 days to decision)
Product code
GEC Brush, Scrub, Operating-Room
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Ballard Medical Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GEC

Trailing 12 months

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

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