# K141009: Fort Defiance Automated Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Fort Defiance Industries, Inc.
- Decided: Dec 16, 2014 after 242 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K820783 (1982). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030789: Amsco Century Steam Sterilizer, STERIS Corporation (2003) Summary page 6.

## Recalls of this device
- Jul 8, 2026 · Class II · Z-2983-2026: 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 
- Aug 19, 2021 · Class II · Z-0121-2022: The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
- May 24, 2018 · Class II · Z-2411-2018: 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 i

## Indications for use
The Fort Defiance Industries, Inc. 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 field use in a variety of austere environments. Cycle: Immediate Use (IUSS) Recommended Use: Unwrapped nonporous (e.g., instruments) and porous items in mixed loads Maximum Load: 36 lbs. Exposure Temperature: 270/132 °F/°C Exposure Time (minutes): 4 Dry Time (minutes): 0 Cycle: Textiles Recommended Use: Textile packs Maximum Load: 3 textile packs* Exposure Temperature: 270/132 °F/°C Exposure Time (minutes): 4 Dry Time (minutes): 5** Cycle: Wrapped Instruments Recommended Use: Wrapped instruments/utensils Maximum Load: 36 lbs. Exposure Temperature: 270/132 °F/°C Exposure Time (minutes): 4 Dry Time (minutes): 20** Cycle: Wrapped Instruments Recommended Use: Wrapped instruments/utensils Maximum Load: 36 lbs. Exposure Temperature: 270/132 °F/°C Exposure Time (minutes): 10 Dry Time (minutes): 20** Cycle: Bowie-Dick Test Recommended Use: Test Maximum Load: NA Exposure Temperature: 273/134 °F/°C Exposure Time (minutes): 3.5 Dry Time (minutes): 0 Cycle: Vacuum Leak Test Recommended Use: Test Maximum Load: NA Exposure Temperature: NA Exposure Time: Test time: 20 Dry Time (minutes): 0 Notes: * AAMI standard 16-towel pack (9"x9"x6") ** Dry times default to established standard conditions, but can be manually increased.

Source page: https://510kreport.com/device/K141009
Methodology: https://510kreport.com/methodology