K242354 is an FDA 510(k) clearance for the AllNEB. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Enchant Tek Co. , Ltd. (Yilan County, TW). The FDA issued a Cleared decision on April 29, 2025, 264 days after receiving the submission on August 8, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K242354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2024 |
| Decision Date | April 29, 2025 |
| Days to Decision | 264 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 |