510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020393Substantially Equivalent

Master & Frank Surgical Drapes (Sterile)

Master & Frank Enterprses Co., Ltd., Taipei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020393 is the FDA 510(k) clearance record for MASTER & FRANK SURGICAL DRAPES (STERILE), a class II device, cleared for Master & Frank Enterprses Co., Ltd. on under FDA product code KKX (Drape, Surgical, Antimicrobial). FDA's definition for product code KKX reads: "Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI". FDA records list one 510(k) clearance for Master & Frank Enterprses Co., Ltd. As of , FDA records show one recall naming K020393.

Clearance record

Decision date
Received
(86 days to decision)
Product code
KKX Drape, Surgical, Antimicrobial
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Master & Frank Enterprses Co., Ltd. 15f-1 No 57 Sec 2, Taipei, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KKX

Trailing 12 months

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

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