Cleared Traditional

SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN

K834077 · Airlife, Inc. · Anesthesiology
Dec 1983
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K834077 is an FDA 510(k) clearance for the SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1983, 17 days after receiving the submission on November 25, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K834077 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1983
Decision Date December 12, 1983
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

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