Skip to content

Decontaminating Machines, LS-850, LS-76, DW/T-216, T-21

by Hamo USA, Inc.

510(k) K911120

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911120 Date3 Feb 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MEC
Device Class
Class II
Regulation
21 CFR Part 880.6992
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Decontaminating Machines, Ls-850, Ls-76, Dw/T-216, T-21 are disinfectors, medical devices used for decontamination purposes. They are classified as Disinfector, Medical Devices. The devices are designed to clean and disinfect equipment and surfaces in a medical setting.

The Decontaminating Machines are supplied in various models, including Ls-850, Ls-76, Dw/T-216, and T-21. They are used in a General Hospital setting and are regulated under the regulation number 880.6992. The devices have been cleared by the FDA with a 510(k) number of K911120, with a decision date of 1994-02-03.

Questions

AI-generated answers, 27 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 are the Decontaminating Machines used for?

    The Decontaminating Machines are used for decontamination purposes in a general hospital setting, designed to clean and disinfect equipment and surfaces.

  • What models are available?

    The Decontaminating Machines are supplied in various models, including LS-850, LS-76, DW/T-216, and T-21.

  • Are the Decontaminating Machines regulated?

    Yes, the Decontaminating Machines are regulated under the regulation number 880.6992 and have been cleared by the FDA with a 510(k) number of K911120.

  • What is the intended setting for the Decontaminating Machines?

    The Decontaminating Machines are intended for use in a general hospital setting.