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Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

by Astell Scientific Limited

510(k) K170304

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 NumberK170304 Date2 Mar 2018ClearedStatusActive

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  • Withdrawn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.

Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers are steam sterilizers designed for general hospital use. These devices are substantially equivalent to predicate sterilizers and are classified as Class II medical devices under regulation number 880.6880.

The Astell UMB series autoclaves/sterilizers are supplied as reusable units and are available in configurations including single or double doors and benchtop or free-standing units. They are manufactured by Astell Scientific Limited and received FDA 510(k) clearance (K170304) on March 2, 2018, for general hospital applications.

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 is the Astell UMB series autoclave/sterilizer intended for?

    The Astell UMB 220, UMB 230, and UMB 240 autoclaves/sterilizers are designed for general hospital use as steam sterilizers, based on their substantial equivalence to predicate devices and classification under regulation number 880.6880 for general hospital applications.

  • Is the Astell UMB series autoclave/sterilizer reusable or single-use?

    The Astell UMB series autoclaves/sterilizers are supplied as reusable units, meaning they are designed for repeated use in hospital settings after proper cleaning and maintenance between cycles.

  • What configurations are available for the Astell UMB series autoclaves/sterilizers?

    The Astell UMB series autoclaves/sterilizers are available in configurations including single or double doors and benchtop or free-standing units, allowing flexibility for different hospital installation and workflow needs.

  • What regulatory pathway was used for the Astell UMB series autoclave/sterilizer?

    The Astell UMB 220, UMB 230, and UMB 240 autoclaves/sterilizers received FDA 510(k) clearance (K170304) on March 2, 2018, through a traditional submission pathway, demonstrating substantial equivalence to predicate sterilizers.

  • Who manufactures the Astell UMB series autoclave/sterilizer and where are they located?

    The Astell UMB series autoclaves/sterilizers are manufactured by Astell Scientific Limited, located at 19-21 Powerscroft Rd., Sidcup, DA14 5DT, United Kingdom, as indicated in the device’s registration and contact information.