# K021504: Tuttnauer Ehs Series Table-Top Autoclave, Model 2540

- Pathway: 510(k) (Abbreviated)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Jul 25, 2002 after 77 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: 1 generation back to K003470 (2001). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003470: Ehs Series Table Top Autoclave, Models 2540 and 3870, Tuttnauer Co., Ltd. (2001)

## Most influential descendants
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves (2011), 10 descendants of its own
- K143311: Pre-vacuum Tabletop Autoclave (2015), 6 descendants of its own
- K213080: T-Edge 10, T-Edge 11 (2022), 2 descendants of its own
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own
- K213457: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 (2022), 1 descendant of its own

## Indications for use
The 2540 EHS Table-Top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices such as dental handpieces, porous, hollow loads, and to sterilize liquids for non-clinical applications. Cycle parameters are as follows: The 2540 EHS Table-Top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices such as dental handpieces, porous, hollow loads, and to sterilize liquids for non-clinical applications. Cycle parameters are as follows:

Source page: https://510kreport.com/device/K021504
Methodology: https://510kreport.com/methodology