510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864116Substantially Equivalent

Anago Isolation Mask (#80-950)

Anago, Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864116 is the FDA 510(k) clearance record for ANAGO ISOLATION MASK (#80-950), a class II device, cleared for Anago, Inc. on under FDA product code LGM (Chamber, Patient Isolation). FDA records list 26 510(k) clearances for Anago, Inc., from to . As of , FDA records show no recalls naming K864116.

Clearance record

Decision date
Received
(35 days to decision)
Product code
LGM Chamber, Patient Isolation
Regulation
21 CFR 880.5450
Device class
Class II
Review panel
General Hospital
Applicant
Anago, Inc. 7524 Mosier View Ct., Fort Worth TX
Third party review
No

Clearances, product code LGM

Trailing 12 months

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

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