# K232658: T-Top 10 & T-Top T-Top 11

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Nov 27, 2023 after 88 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: 7 generations back to K003470 (2001). 16 ancestors in all.
1 later device descends 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)
- K213080: T-Edge 10, T-Edge 11, Tuttnauer, Ltd. (2022) Summary page 5.

## Most influential descendants
- K250168: Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (2025), 0 descendants of its own

## Indications for use
The T-Top 10 & T-Top 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 & dental offices). The T-Top 10 and T-Top 11 devices are validated for use in: • Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles). • Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

Source page: https://510kreport.com/device/K232658
Methodology: https://510kreport.com/methodology