510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K211097Substantially Equivalent

Banyan USA Surgical Mask Level 3

Banyan USA, LLC, Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211097 is the FDA 510(k) clearance record for Banyan USA Surgical Mask Level 3, a class II device, cleared for Banyan USA, LLC on under FDA product code FXX (Mask, Surgical). FDA records list one 510(k) clearance for Banyan USA, LLC. As of , FDA records show no recalls naming K211097.

Clearance record

Decision date
Received
(162 days to decision)
Product code
FXX Mask, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Banyan USA, LLC 390 Oser Ave., Hauppauge NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FXX

Trailing 12 months
8 clearances under product code FXX in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FXX, trailing twelve months
MonthClearances
November 20251
December 20252
January 20262
February 20261
March 20262
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260