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I-Neb AAD System

by Profile Therapeutics Plc

510(k) K042991

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 NumberK042991 Date23 Sep 2005ClearedStatusActive

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  • Withdrawn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
CAF
Device Class
Class II
Regulation
21 CFR Part 868.5630
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 I-Neb AAD System is an ultrasonic vibrating mesh nebulizer designed to aerosolize liquid medication. It is intended for the inhalation of approved medications by patients.

This device is suitable for use in home care, nursing home, sub-acute institution, or hospital environments. The system is identified by FDA 510(k) number K042991.

Other devices from Profile Therapeutics Plc

Questions

AI-generated answers, 26 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 primary function of the I-Neb AAD System?

    The I-Neb AAD System is an ultrasonic vibrating mesh nebulizer. Its primary function is to aerosolize liquid medication, allowing patients to inhale the prescribed treatment.

  • In what environments can the I-Neb AAD System be used?

    This device is suitable for use across a range of clinical and residential environments, including home care, nursing homes, sub-acute institutions, and hospital settings.

  • What is the regulatory status of this nebulizer?

    The I-Neb AAD System is identified by FDA 510(k) number K042991. It received a decision of Substantially Equivalent following a traditional submission process.