Data / Medical devices / United States / Fort Defiance Industries LLC
Fort Defiance Industries LLC: FDA-registered device maker in Loudon, TN, United States, 2 510(k) clearances
Fort Defiance Industries LLC is registered with the FDA (registration 3011421558) in Loudon, TN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 2, 2022. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011421558
- Address
- 2411 Maremont Pkwy, Loudon, TN, United States, 37774
- Owner or operator
- FORT DEFIANCE INDUSTRIES (10048347)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 1, 2015
- Registered through
- 2026
- Brand names listed
- Automated Field Steam Sterilizer, FRONT-LINE FIELD STERILIZER FL120 & FL135, P2131, P2131 Automated Field Steam Sterilizer, P2131 Field Steam Sterilizer, P2131 Steam Sterilizer, P2131 Sterilizer, Quadriciser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Non-Measuring | ION | 1 | Manufacturer | accessdata.fda.gov |
| Sterilizer, Steam | FLE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2022 | K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 | FLE | Substantially Equivalent | Fort Defiance Industries, LLC | accessdata.fda.gov |
| December 16, 2014 | K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER | FLE | Substantially Equivalent | Fort Defiance Industries, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 8, 2026 | 99371 | Class II | Ongoing | 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. | accessdata.fda.gov |
| August 19, 2021 | 88628 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 24, 2018 | 80293 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
Updated August 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.