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
K831357Substantially Equivalent

Boundary Headwear

Procter & Gamble Mfg. Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831357 is the FDA 510(k) clearance record for BOUNDARY HEADWEAR, a class I device, cleared for Procter & Gamble Mfg. Co. on under FDA product code FYF (Cap, Surgical). FDA records list 72 510(k) clearances for Procter & Gamble Mfg. Co., from to . As of , FDA records show no recalls naming K831357.

Clearance record

Decision date
Received
(37 days to decision)
Product code
FYF Cap, Surgical
Regulation
21 CFR 878.4040
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Procter & Gamble Mfg. Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FYF

Trailing 12 months

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

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