510(k) · Cleared
ClearedFRONT-LINE Field Sterilizer (FL135)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fort Defiance Industries, LLC · FLE Sterilizer, Steam
Cleared on Mar 7, 2025 as substantially equivalent to K213457 (Fort Defiance Industries, LLC, 2022) after an 86-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Mar 7, 2025
- Review
- 86 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K003470 (2001). 10 ancestors in all, the oldest K850264 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 5 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 4 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 3 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 2 generations backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- 1 generation backK213457 Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort…Fort Defiance Industries, LLC · 2022
- This deviceK243801 FRONT-LINE Field Sterilizer (FL135)Fort Defiance Industries, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −5 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −4 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −3 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −2 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| −1 | K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance… | Fort Defiance Industries, LLC | 2022 | — |
| 0 (this device) | K243801 | FRONT-LINE Field Sterilizer (FL135) | Fort Defiance Industries, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries…Summary page 7…Sterilizer Class II Device - 21 CFR 880.6880 Product Code FLE 2. Predicate Device K213457, FRONT-LINE Field Sterilizer, Model FL135, product code FLE, cleared March 2, 2022 3. Description of Device This c… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. CYCLE EXPOSURE EXPOSURE DRY TIME LOAD TEMP* (oF/oC) TIME (MINUTES) (MINUTES) IMMEDIATE 25 LBS. 270/ 132 4 0 USE (IUSS) 275 / 135 3 0 TEXTILES 3 TEXTILE…
Read the full statement (128 words)
The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
CYCLE EXPOSURE EXPOSURE DRY TIME
LOAD TEMP* (oF/oC) TIME (MINUTES)
(MINUTES)
IMMEDIATE 25 LBS. 270/ 132 4 0
USE (IUSS) 275 / 135 3 0
TEXTILES 3 TEXTILE 250/ 121 30 15
PACKS** 270 /132 4 15
275 / 135 3 15
WRAPPED 25 LBS. 250/121 30 35
INSTR./ 270/132 4 30
POUCHES 275/135 3 30
HANDPIECES 12 HANDPIECES 270/132 4 30
275/135 3 30
NOTES:
* THE ANSI/AAMI ST55:2016 MINIMUM TEMPERATURE IS LISTED FOR ALL CYCLES.
** AAMI STANDARD TEXTILE PACK (9 TOWELS - ST 55 SECTION 5.7.1.1).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243801: FRONT-LINE Field Sterilizer (FL135).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243801
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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