Cleared Traditional

K260147 - Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) (FDA 510(k) Clearance)

Mar 2026
Decision
52d
Days
Class 2
Risk

K260147 is an FDA 510(k) clearance for the Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036). This device is classified as 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 March 13, 2026, 52 days after receiving the submission on January 20, 2026.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K260147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2026
Decision Date March 13, 2026
Days to Decision 52 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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