Aim (N/A)

FDA 510(k) K240937 · Inventeur, LLC

Substantially Equivalent

510(k) numberK240937

Submission

Device name
Aim (N/A)
Applicant
Inventeur, LLC
Lewes, DE, US
Received
April 5, 2024
Decision date
December 16, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1400
Specialty
Anesthesiology

Other 510(k)s with product code CCK

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K251641GF-310R Multigas Unit (GF-310R)CCK · Traditional Nihon Kohden Corporation08/12/2026SE
K261633VisuBreathCCK · Traditional Affirm Medical Technologies II, LLC07/14/2026SE
K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)CCK · Traditional Covidien, LLC05/01/2026SE
K250148Medical Gas Analyzer (AG200)CCK · Traditional Prior Care Science Technology, Ltd.08/28/2025SE
K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)CCK · Traditional Nihon Kohden Corporation06/10/2025SE
K2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2…CCK · Traditional Barbaras Development, Inc.06/04/2025SE
K230915AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen MaskCCK · Traditional Vyaire Medical, Inc.11/12/2024SE
K212425MicroTrend SystemCCK · Traditional Exostat Medical, Inc.11/07/2024SE
K222511Oxy2ProCCK · Traditional Southmedic, Inc.11/21/2023SE
K213767Endure ETCO2/02 Nasal CannulaCCK · Traditional Endure Industries, Inc.09/12/2023SE

Questions and answers

When was Aim (N/A) cleared by the FDA?

Aim (N/A) (K240937) received a 510(k) decision of Substantially Equivalent on December 16, 2024, 255 days after the submission was received.

What is the product code of K240937?

The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.