K250697 is an FDA 510(k) clearance for the Electric Nasal Aspirator (BC026, BC025, BC023). 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 April 23, 2025, 47 days after receiving the submission on March 7, 2025.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K250697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | BTA - Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |