# K240937: AIM (N/A)

- Pathway: 510(k) (Traditional)
- Applicant: Inventeur, LLC
- Decided: Dec 16, 2024 after 255 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896691 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140473: Dualguard, Flexicare Medical, Ltd. (2014) Summary page 5.

## Indications for use
AlIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

Source page: https://510kreport.com/device/K240937
Methodology: https://510kreport.com/methodology