# K213080: T-Edge 10, T-Edge 11

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer, Ltd.
- Decided: Jan 4, 2022 after 103 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). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143311: Pre-vacuum Tabletop Autoclave, Tuttnauer U.S.A Co, Ltd. (2015) Summary page 7.
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves, Tuttnauer Co., Ltd. (2011) Summary page 7.

## Most influential descendants
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own
- K250168: Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (2025), 0 descendants of its own

## Indications for use
The T-Edge 10 & T-Edge 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices). The T-Edge 10 & T-Edge 11 are validated for use in: • Sterilizing fabric packs / textiles • Sterilizing dental handpieces The following tables show the cycles that were validated for Class S and Class B, including sterilization temperature, sterilization time in minutes and dry time in minutes and maximum loads:

Source page: https://510kreport.com/device/K213080
Methodology: https://510kreport.com/methodology