K213457 is an FDA 510(k) clearance for the Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries 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 2, 2022, 126 days after receiving the submission on October 27, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K213457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2021 |
| Decision Date | March 02, 2022 |
| Days to Decision | 126 days |
| Submission Type | Abbreviated |
| 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 |