K244035 is an FDA 510(k) clearance for the Portable mesh nebulizer (JM821). This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Shenzhen Jermei Medical Device Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 19, 2025, 263 days after receiving the submission on December 30, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K244035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2024 |
| Decision Date | September 19, 2025 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |