510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883964Substantially Equivalent

Airlife Misty Neb Medication System W/filter

Baxter Healthcare Corporation, Valencia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883964 is the FDA 510(k) clearance record for AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER, a class II device, cleared for Baxter Healthcare Corp on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K883964.

Clearance record

Decision date
Received
(71 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Baxter Healthcare Corp 27200 N. Tourney Rd., Valencia CA
Third party review
No

Clearances, product code CAF

Trailing 12 months
4 clearances under product code CAF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CAF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260