510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821128Substantially Equivalent

Disposable Thermoplastic Rubber Mouth

Airlife, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821128 is the FDA 510(k) clearance record for DISPOSABLE THERMOPLASTIC RUBBER MOUTH, a class I device, cleared for Airlife, Inc. on under FDA product code BYP (Mouthpiece, Breathing). FDA records list 76 510(k) clearances for Airlife, Inc., from to . As of , FDA records show no recalls naming K821128.

Clearance record

Decision date
Received
(23 days to decision)
Product code
BYP Mouthpiece, Breathing
Regulation
21 CFR 868.5620
Device class
Class I
Review panel
Anesthesiology
Applicant
Airlife, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYP

Trailing 12 months

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

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