510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K881067Substantially Equivalent

Non Conductive, Single Use Anesthesia Face Mask

Medesign, Inc., Verona NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881067 is the FDA 510(k) clearance record for NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK, a class I device, cleared for Medesign, Inc. on under FDA product code BSJ (Mask, Gas, Anesthetic). FDA records list one 510(k) clearance for Medesign, Inc. As of , FDA records show no recalls naming K881067.

Clearance record

Decision date
Received
(10 days to decision)
Product code
BSJ Mask, Gas, Anesthetic
Regulation
21 CFR 868.5550
Device class
Class I
Review panel
Anesthesiology
Applicant
Medesign, Inc. 685 Bloomfield Ave., Verona NJ
Third party review
No

Clearances, product code BSJ

Trailing 12 months

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

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