510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K020357Substantially Equivalent

800 Series Easyneb Nebulizer

Medtronic, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020357 is the FDA 510(k) clearance record for 800 SERIES EASYNEB NEBULIZER, a class II device, cleared for Nellcor Puritan Bennett, Inc. on under FDA product code CAF (Nebulizer (Direct Patient Interface)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show one recall naming K020357.

Clearance record

Decision date
Received
(184 days to decision)
Product code
CAF Nebulizer (Direct Patient Interface)
Regulation
21 CFR 868.5630
Device class
Class II
Review panel
Anesthesiology
Applicant
Nellcor Puritan Bennett, Inc. 4280 Hacienda Dr., Pleasanton CA
510(k) summary
Summary PDF
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