# K243801: FRONT-LINE Field Sterilizer (FL135)

- Pathway: 510(k) (Special)
- Applicant: Fort Defiance Industries, LLC
- Decided: Mar 7, 2025 after 86 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: 6 generations back to K003470 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213457: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135, Fort Defiance Industries, LLC (2022) Summary page 7.

## Indications for use
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).

Source page: https://510kreport.com/device/K243801
Methodology: https://510kreport.com/methodology