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AIROCIDE TI02

by Kes Science & Technology, Inc.

510(k) K023830

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 NumberK023830 Date4 Feb 2003ClearedStatusActive

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  • Withdrawn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
FRA
Device Class
Class II
Regulation
21 CFR Part 880.6500
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 AIROCIDE TI02 is a medical ultraviolet air purifier designed to draw ambient air from enclosed spaces and remove airborne contaminants. It functions by mineralizing pathogens, molds, and volatile organic compounds through ultraviolet technology. The device is classified under product code FRA and regulation number 880.6500 as a Purifier, Air, Ultraviolet, Medical.

This device is intended for use in general hospital settings, including wards, operating rooms, and treatment rooms. It operates as a single-purpose air purification system and is subject to FDA 510(k) regulatory review under number K023830. Storage and handling instructions are not specified in the available data, and MRI safety compatibility is not documented.

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 is the AIROCIDE TI02 used for?

    The AIROCIDE TI02 is a medical ultraviolet air purifier designed to remove airborne contaminants from enclosed spaces in general hospital settings, including wards, operating rooms, and treatment rooms. It mineralizes pathogens, molds, and volatile organic compounds using ultraviolet technology.

  • How is the AIROCIDE TI02 supplied and is it single-use or reusable?

    The device is supplied as a single-purpose air purification system. The available data does not specify whether it is single-use or reusable, nor does it provide detailed storage and handling instructions.

  • What regulatory approvals does the AIROCIDE TI02 have?

    The AIROCIDE TI02 is classified under product code FRA and regulation number 880.6500 as a Purifier, Air, Ultraviolet, Medical. It has undergone FDA 510(k) regulatory review under number K023830 and was determined to be substantially equivalent.

  • Is the AIROCIDE TI02 compatible with MRI environments?

    MRI safety compatibility for the AIROCIDE TI02 is not documented in the available data. Users should consult the manufacturer directly for specific information regarding MRI compatibility.