# K250168: Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Lucas Lifecare
- Decided: Dec 30, 2025 after 343 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: 8 generations back to K003470 (2001). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232658: T-Top 10 & T-Top T-Top 11, Tuttnauer U.S.A Co, Ltd. (2023) Summary page 5.

## Indications for use
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is intended to be used in medical, dental, surgical, healthcare, and laboratory applications (e.g hospitals, nursing homes, surgical centers, healthcare clinics, or dental offices) to sterilize heat and moisture-stable reusable loads that are solid, hollow, porous, or delicate, in either wrapped or unwrapped arrangements. Validated sterilization cycles of LifeUltra include: Class B cycles • 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments, hand pieces, textiles, and porous loads (max 7 kg). • 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate or wrapped/unwrapped loads (max 7 kg). Class S cycles • 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments and hand pieces (max 7 kg). • 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate loads (max 7 kg).

Source page: https://510kreport.com/device/K250168
Methodology: https://510kreport.com/methodology