Cleared Traditional

Electric Nasal Aspirator (BC026, BC025, BC023)

K250697 · Shenzhen Kingboom Technology Co., Ltd. · Ear, Nose, Throat
Apr 2025
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K250697 is an FDA 510(k) clearance for the Electric Nasal Aspirator (BC026, BC025, BC023), a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Shenzhen Kingboom Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 23, 2025, 47 days after receiving the submission on March 7, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K250697 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2025
Decision Date April 23, 2025
Days to Decision 47 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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