Cleared Traditional

Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)

K233901 · Shenzhen Desida Technology Co., Ltd. · Ear, Nose, Throat
Mar 2024
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K233901 is an FDA 510(k) clearance for the Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009), 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 March 20, 2024, 100 days after receiving the submission on December 11, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K233901 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2023
Decision Date March 20, 2024
Days to Decision 100 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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