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Aim

by Inventeur, LLC

510(k) K240937

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 NumberK240937 Date16 Dec 2024ClearedStatusActive

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  • Withdrawn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)

Full name
Aim (N/a)
510(k) Number
FDA Product Code
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
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 Aim is a carbon dioxide gas analyzer designed for pharyngeal oxygen delivery. This device integrates oxygenation, capnography, and airway rescue into a single bite block for use during sedation.

This device is supplied by Inventeur, LLC and has received FDA 510(k) clearance under K240937. It is classified as a Class II medical device under regulation 21 CFR 868.1400.

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 Aim device?

    The Aim is a carbon dioxide gas analyzer specifically designed for pharyngeal oxygen delivery. It functions by integrating oxygenation, capnography, and airway rescue capabilities into a single bite block for use during sedation procedures.

  • What is the regulatory status of the Aim device?

    The Aim device, manufactured by Inventeur, LLC, has received FDA 510(k) clearance under K240937. It is classified as a Class II medical device under regulation 21 CFR 868.1400.

  • In what clinical setting is the Aim device intended to be used?

    The device is designed for use during sedation. Its integrated design allows for simultaneous oxygen delivery and capnography monitoring while providing airway rescue support through a bite block configuration.