Lamelli Oxygen Enriched Environment System & Tent

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K884018 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• What clinical setting is the Lamelli Oxygen Enriched Environment System & Tent primarily used in, and how does it function there?

  The Lamelli Oxygen Enriched Environment System & Tent is primarily designed for use in anesthesia settings to create a controlled, oxygen-rich atmosphere for patients within a tented enclosure. It functions by generating supplemental oxygen to maintain elevated oxygen levels inside the tent, which can be particularly useful during procedures requiring precise oxygen management, such as anesthesia induction or respiratory support.

• Is the Lamelli Oxygen Enriched Environment System & Tent a single-use or reusable device, and what does this mean for maintenance?

  The Lamelli Oxygen Enriched Environment System & Tent is explicitly described as a reusable device. This means it is intended for repeated use in clinical settings, and proper cleaning, sterilization, and maintenance protocols must be followed between uses to ensure safety, functionality, and compliance with regulatory standards.

• What regulatory pathway was followed for FDA clearance of this device, and what does the product code (CAW) indicate?

  The Lamelli Oxygen Enriched Environment System & Tent received FDA 510(k) clearance under the classification of *Generator, Oxygen, Portable* with a decision of *Substantially Equivalent (SESE)*. The product code CAW categorizes it as a portable oxygen generator, aligning with its intended use in controlled environments like anesthesia. The clearance was granted through a traditional review process by the Anesthesiology Advisory Committee (AN).

• How would you describe the portability of this device, and what practical implications does that have for its use?

  The device is explicitly labeled as a *portable* oxygen generator, meaning it is designed to be moved between locations within a clinical setting without significant difficulty. This portability allows for flexible deployment in operating rooms, recovery areas, or other spaces requiring an oxygen-enriched environment during procedures like anesthesia. Its compact and mobile nature ensures accessibility while maintaining functionality.

• Are there multiple models or sizes available for the Lamelli Oxygen Enriched Environment System & Tent, and if so, how might they differ?

  The provided data does not specify distinct models or sizes for the Lamelli Oxygen Enriched Environment System & Tent, but the inclusion of multiple FEI numbers (e.g., 3010440667, 3008507279) suggests variations may exist under different registrations. These differences could relate to technical specifications, output capacities, or minor design adaptations. For precise details on available models, consulting the manufacturer’s documentation or support team is recommended.