# Steam Sterilizer 2545D

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/steam-sterilizer-2545d-fle>
- Manufacturer: [Ningbo Ican Machines Co., Ltd.](https://devicerts.com/manufacturers/ningbo-ican-machines-co-ltd) (China)
- Name in the registry: Steam Sterilizer (2545D)
- Device class: Class II (US FDA)
- FDA product code: FLE

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Steam Sterilizer 2545D is a Class II medical device designed for steam sterilization of surgical instruments, devices, and supplies. It employs moist heat to eliminate microorganisms, ensuring sterile conditions for healthcare settings by achieving high-temperature, high-pressure cycles that meet regulatory standards for decontamination.

This device is intended for use in general hospital environments and is supplied as a reusable medical instrument. It operates under FDA 510(k) clearance and MDR authorization, adhering to steam sterilization protocols for reusable items. The sterilizer is not MRI-safe and requires proper storage, maintenance, and adherence to manufacturer guidelines to ensure effective and safe operation.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K243994 · decision 2025-06-06 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K243994 [FDA 510(k)]
- FDA product code: FLE [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 880.6880 [FDA 510(k)]
- Advisory committee: General Hospital [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Steam Sterilizer 2545D, Ningbo Ican Machines Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/steam-sterilizer-2545d-fle (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/steam-sterilizer-2545d-fle.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/steam-sterilizer-2545d-fle
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.