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3 LPM Oxygen Concentrator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K952037

by Devilbiss Health Care, Inc.

Identifiers

510(k) Number
K952037 FDA 510(k)
FDA Product Code
CAW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5440 FDA 510(k)
Regulation Number
868.5440 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 3 LPM Oxygen Concentrator is a medical device classified as a generator for oxygen, intended to provide oxygen therapy. It is designed to deliver oxygen at a flow rate of 3 liters per minute, as specified in its device name.

The device is supplied as a portable oxygen concentrator and is intended for single-use in a medical setting. It is not specified as reusable, sterile, or MRI-safe. The device is regulated under FDA 510(k) authorization, with the submission reviewed by the Anesthesiology advisory committee.

Frequently asked questions

What flow rate does the 3 LPM Oxygen Concentrator provide?

It delivers oxygen at a constant rate of 3 liters per minute, as indicated by the device name. This flow is suitable for patients who need low‑to‑moderate supplemental oxygen during therapy.

Is the concentrator intended for single‑use or multiple uses?

The device is supplied as a portable unit intended for single‑use in a medical setting. It is not marketed as reusable, so each unit is used for one patient or treatment episode before disposal.

Does the device require sterilization before use?

The product description does not list the concentrator as sterile or requiring sterilization. It is delivered non‑sterile and can be used directly in a clinical environment without additional sterilization steps.

How is the 3 LPM Oxygen Concentrator regulated?

Regulatory clearance was obtained through an FDA 510(k) submission reviewed by the Anesthesiology advisory committee, with a decision of substantial equivalence. This indicates the device meets the necessary safety and performance standards for its class.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DeVilbiss Healthcare DEVILBISS IGO PORTABLE OXYGEN CONCENTRATOR from ..., DeVilbiss Healthcare Oxygen Concentrators and Accessories, Oxygen Concentrators & Respiratory Products - Drive Medical, Amazon.com: Devilbiss Oxygen Concentrator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Devilbiss Health Care, Inc.

Sources (1)

  • FDA 510(k) K952037 24 fields · synced Sep 22, 2026