510(k) · Cleared
Recalled · Class II · 2026Fort Defiance Automated Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fort Defiance Industries, Inc. · FLE Sterilizer, Steam
Cleared on Dec 16, 2014 as substantially equivalent to K030789 (STERIS Corporation, 2003) after a 242-day review. Its family tree reaches back 5 generations to 1982. It has been recalled 3 times.
- Decided
- Dec 16, 2014
- Review
- 242 days
- Class
- Class II
- Product code
- FLE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820783 (1982). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK820783 Castle Microcomputer Sterilizer ControlSybron Corp. · 1982
- 4 generations backK970907 Castle Series 100 Steam Sterilizers (Straightline)Getinge/Castle, Inc. · 1997
- 3 generations backK994314 Castle Series 100HC Steam SterilizersGetinge/Castle, Inc. · 2000
- 2 generations backK012573 Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC…Getinge/Castle, Inc. · 2001
- 1 generation backK030789 Amsco Century Steam SterilizerSTERIS Corporation · 2003
- This deviceK141009 Fort Defiance Automated Steam SterilizerFort Defiance Industries, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820783 | Castle Microcomputer Sterilizer Control | Sybron Corp. | 1982 | — |
| −4 | K970907 | Castle Series 100 Steam Sterilizers (Straightline) | Getinge/Castle, Inc. | 1997 | — |
| −3 | K994314 | Castle Series 100HC Steam Sterilizers | Getinge/Castle, Inc. | 2000 | — |
| −2 | K012573 | Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… | Getinge/Castle, Inc. | 2001 | — |
| −1 | K030789 | Amsco Century Steam Sterilizer | STERIS Corporation | 2003 | — |
| 0 (this device) | K141009 | Fort Defiance Automated Steam Sterilizer | Fort Defiance Industries, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030789 | Amsco Century Steam SterilizerSummary page 6…Sterilizer Classification Name: Steam Sterilizer (21 CFR 880.6880) Product Code FLE 2. Predicate Device K030789, Amsco Century Steam Sterilizer, product code [FLE] cleared March 26, 2003 3. Description of Device The Fort Defiance I… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2026 | Class II | Z-2983-2026 | Component design/selection | 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. |
| Aug 19, 2021 | Class II | Z-0121-2022 | Device Design | 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 | Device Design | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K030789.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
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…
Read the full statement (213 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141009: Fort Defiance Automated Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141009
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026