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Belimed Steam Sterilizer Top 5000, Series 8, Models: 6-0-12 VS1 and VS2

by Belimed Sauter AG

510(k) K090339

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090339 Date23 Sep 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 19 Sep 2026

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

This device is a steam sterilizer, as defined by its classification name Sterilizer, Steam. It is intended for the sterilization of heat and moisture-stable materials in a general hospital setting.

The device is supplied as a reusable unit, with FDA 510(k) clearance under product code FLE and regulation number 880.6880. It was determined to be substantially equivalent and received clearance on September 23, 2009, following a traditional 510(k) submission.

Other devices from Belimed Sauter AG

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of materials can the Belimed Steam Sterilizer Top 5000 sterilize, and where is it primarily used?

    The Belimed Steam Sterilizer Top 5000 is designed for sterilizing heat and moisture-stable materials, making it suitable for general hospital settings. It is intended for use in environments where reusable medical instruments, surgical tools, and other heat-resistant items need to be sterilized to ensure safety and compliance with infection control standards.

  • Is the Belimed Steam Sterilizer Top 5000 a single-use or reusable device, and how is it supplied?

    The Belimed Steam Sterilizer Top 5000 is a reusable unit, meaning it is built to be used repeatedly in clinical settings. It is not a disposable device, and its design allows for long-term use in hospitals or healthcare facilities where consistent sterilization of medical instruments is required.

  • What regulatory pathway was followed for FDA clearance of the Belimed Steam Sterilizer Top 5000, and when was it cleared?

    The Belimed Steam Sterilizer Top 5000 received FDA clearance through a traditional 510(k) submission, which demonstrated its substantial equivalence to a legally marketed predicate device. It was cleared on September 23, 2009, under product code FLE and regulation number 880.6880, confirming its compliance with U.S. regulatory standards for steam sterilizers.

  • What models are included in the Belimed Steam Sterilizer Top 5000 Series 8, and how do I identify the correct model for my facility?

    The Belimed Steam Sterilizer Top 5000 Series 8 includes two specific models: 6-0-12 VS1 and 6-0-12 VS2. These models are part of the same series, so compatibility depends on your facility’s specific sterilization needs, chamber size requirements, and existing infrastructure. Consulting with Belimed Sauter AG or a representative can help ensure the correct model aligns with your operational workflow.