Cleared Special

AERONEB PRO

K120939 · Aerogen, Ltd. · Anesthesiology
Apr 2012
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K120939 is an FDA 510(k) clearance for the AERONEB PRO, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Aerogen, Ltd. (Galway, IE). The FDA issued a Cleared decision on April 26, 2012, 28 days after receiving the submission on March 29, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K120939 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2012
Decision Date April 26, 2012
Days to Decision 28 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

Similar Devices — CAF Nebulizer (direct Patient Interface)

All 506
eRapid with eTrack System
K251572 · Pari Respiratory Equipment, Inc. · Dec 2025
Mesh Nebulizer (H6)
K251659 · Qingdao Future Medical Technology Co., Ltd. · Nov 2025
Portable mesh nebulizer (JM821)
K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 2025
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
K243468 · Joytech Healthcare Co. , Ltd. · Jul 2025
HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025