Cleared Traditional

Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)

K243468 · Joytech Healthcare Co. , Ltd. · Anesthesiology
Jul 2025
Decision
236d
Days
Class 2
Risk

About This 510(k) Submission

K243468 is an FDA 510(k) clearance for the Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103), a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 2, 2025, 236 days after receiving the submission on November 8, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K243468 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2024
Decision Date July 02, 2025
Days to Decision 236 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

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