K242028 is an FDA 510(k) clearance for the Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026). This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Dongguanshi Yiyingmei Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on November 19, 2024, 131 days after receiving the submission on July 11, 2024.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K242028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2024 |
| Decision Date | November 19, 2024 |
| Days to Decision | 131 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 |