# K243994: Steam Sterilizer (2545D)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Ican Machines Co., Ltd.
- Decided: Jun 6, 2025 after 162 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 K220102 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220102: MOST-T Autoclave, Shinva Medical Instrument Co., Ltd. (2022) Summary page 5.

## Indications for use
The 2545D tabletop Steam Sterilizer is 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 2545D was validated for use in: Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.

Source page: https://510kreport.com/device/K243994
Methodology: https://510kreport.com/methodology