Cleared Traditional

Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)

K244033 · Shenzhen Desida Technology Co., Ltd. · Ear, Nose, Throat
May 2025
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K244033 is an FDA 510(k) clearance for the Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610), a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Shenzhen Desida Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 16, 2025, 137 days after receiving the submission on December 30, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K244033 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2024
Decision Date May 16, 2025
Days to Decision 137 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

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