FORT DEFIANCE AUTOMATED STEAM STERILIZER— 510(k) K141009
Substantially EquivalentFort Defiance Industries, Inc.
FDA 510(k) clearance K141009 for FORT DEFIANCE AUTOMATED STEAM STERILIZER, Substantially Equivalent on 2014-12-16. Applicant: Fort Defiance Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Fort Defiance Industries, Inc.
- Product code
- Code FLE
- Device class
- Class 2
- Regulation
- 21 CFR 880.6880
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Loudon, TN, US
Recent devices under product code FLE
view allAdverse events under product code FLE
product code FLE- Malfunction
- 444
- Total
- 444
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141009
K-number listed on FDA's recall record- Z-2983-2026 — Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
- Z-0121-2022 — P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
- 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141009.
Data sourced from openFDA. This site is unofficial and independent of the FDA.