Fort Defiance Industries, LLC
Loudon, TN, US
FORT DEFIANCE INDUSTRIES LLC appears in FDA device records in Loudon, TN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Fort Defiance Industries, LLC between 2014 and 2025. The busiest year on record is 2014, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243801 | FRONT-LINE Field Sterilizer (FL135) | FLE | Substantially Equivalent | |
| K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 | FLE | Substantially Equivalent | |
| K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER | FLE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011421558 | 3011421558 | FORT DEFIANCE INDUSTRIES LLC | 2411 MAREMONT PKWY, Loudon, TN 37774 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2983-2026 | Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131 | The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path. | Class II | Open, Classified | |
| Z-0121-2022 | P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641 | The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground. | Class II | Open, Classified | |
| Z-2411-2018 | FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments. | During long-term storage (i.e. military depot), the interaction of stagnant water and dissimilar metals in the plumbing of the P2131 device produces deposits in the water system that can potentially interfere with the rear sight gauge and / or the water liquid level switch. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain