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Aeromist LT, Model HCS15004

by Medline Industries, Inc.

510(k) K031686

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

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031686 Date21 Jan 2004ClearedStatusActive

Official records

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  • Withdrawn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
BTI
Device class
Class II
Regulation
21 CFR Part 868.6250
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Aeromist LT, Model HCS15004 is a portable air compressor designed for delivering aerosolized medication. Classified as a Compressor, Air, Portable, it generates compressed air to drive nebulizers, facilitating the administration of inhaled therapies in clinical settings such as anesthesia or respiratory care.

This device is supplied as a reusable, non-sterile Class II medical device under FDA 510(k) clearance (K031686). It is intended for use in hospital or clinical environments, adhering to regulatory standards for portable compressors. The device operates on standard electrical power and is not MRI-compatible. No specific sterility or single-use requirements are noted in the regulatory data.

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