Chrysalis Intelligence · Sponsors · Fort Defiance Industries, LLC

Fort Defiance Industries, LLC

Loudon, TN, US · 2 510(k) clearances · 1 recalls

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Total clearances
2
2022-03-02 → 2025-03-07
Last 12 months
0
Product codes
1
Most recent
2025-03-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FLE Sterilizer, Steam Class II General Hospital 2 2025-03-07
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2021-08-19
DateSeverityStatusRecall # ProductCodeReason
2021-08-19 Class II Ongoing 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.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-03-07 K243801 FRONT-LINE Field Sterilizer (FL135) FLE Class II General Hospital
2022-03-02 K213457 Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 FLE Class II General Hospital
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence