510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811908Substantially Equivalent

Imv Manifolds

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

K811908 is the FDA 510(k) clearance record for IMV MANIFOLDS, a class II device, cleared for Airlife, Inc. on under FDA product code CBO (Attachment, Intermittent Mandatory Ventilation (Imv)). FDA records list 76 510(k) clearances for Airlife, Inc., from to . As of , FDA records show no recalls naming K811908.

Clearance record

Decision date
Received
(15 days to decision)
Product code
CBO Attachment, Intermittent Mandatory Ventilation (Imv)
Regulation
21 CFR 868.5955
Device class
Class II
Review panel
Anesthesiology
Applicant
Airlife, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CBO

Trailing 12 months

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

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