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Steam Sterilizer 2545D

by Ningbo Ican Machines Co., Ltd.

510(k) K243994

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243994↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243994 Date6 Jun 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243994 decided 6 Jun 2025 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
FLE
Device class
Class II
Regulation
21 CFR Part 880.6880
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K243994

5 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K243994
UDI-DISize and differences
Flight Dental Systems Clave16+
FLIGHT DENTAL SYSTEMS USA INC.
Clave16+ / Clave16+D178CLAVE16 —On the market
Flight Dental Systems Clave23+
FLIGHT DENTAL SYSTEMS USA INC.
Clave23+ / Clave23+D178CLAVE23 —On the market
Flight Dental Systems Clave28+
FLIGHT DENTAL SYSTEMS USA INC.
Clave28+ / Clave28+D178CLAVE28 —On the market
Flight Dental Systems Clave45+
FLIGHT DENTAL SYSTEMS USA INC.
Clave45+ / Clave45+D178CLAVE45 —On the market
Flight Dental Systems Clave8+
FLIGHT DENTAL SYSTEMS USA INC.
Clave8+ / Clave8+D178CLAVE8 —On the market

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, Steam).

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