510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K854161Substantially Equivalent

Sur-Fit Face Mask

Anesthesia Respiratory Technology, Inc., Noblesville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854161 is the FDA 510(k) clearance record for SUR-FIT FACE MASK, a class I device, cleared for Anesthesia Respiratory Technology, Inc. on under FDA product code BSJ (Mask, Gas, Anesthetic). FDA records list one 510(k) clearance for Anesthesia Respiratory Technology, Inc. As of , FDA records show no recalls naming K854161.

Clearance record

Decision date
Received
(25 days to decision)
Product code
BSJ Mask, Gas, Anesthetic
Regulation
21 CFR 868.5550
Device class
Class I
Review panel
Anesthesiology
Applicant
Anesthesia Respiratory Technology, Inc. P.O. Box 68, Noblesville IN
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