Cleared Traditional

eRapid Nebulizer System

K223840 · Pari Respiratory Equipment, Inc. · Anesthesiology
Aug 2023
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K223840 is an FDA 510(k) clearance for the eRapid Nebulizer System, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Pari Respiratory Equipment, Inc. (Midlothian, US). The FDA issued a Cleared decision on August 11, 2023, 232 days after receiving the submission on December 22, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K223840 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2022
Decision Date August 11, 2023
Days to Decision 232 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

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