# K213457: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

- Pathway: 510(k) (Abbreviated)
- Applicant: Fort Defiance Industries, LLC
- Decided: Mar 2, 2022 after 126 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003470 (2001). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves, Tuttnauer Co., Ltd. (2011) Summary page 6.

## Most influential descendants
- K243801: FRONT-LINE Field Sterilizer (FL135) (2025), 0 descendants of its own

## Indications for use
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves 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.

Source page: https://510kreport.com/device/K213457
Methodology: https://510kreport.com/methodology