K243801 is an FDA 510(k) clearance for the FRONT-LINE Field Sterilizer (FL135). This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Fort Defiance Industries, LLC (Loudon, US). The FDA issued a Cleared decision on March 7, 2025, 86 days after receiving the submission on December 11, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K243801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2024 |
| Decision Date | March 07, 2025 |
| Days to Decision | 86 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |