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Precision Oxygen Concentrator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072348

by Precision Medical, Inc.

Identifiers

510(k) Number
K072348 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 Precision Oxygen Concentrator is a portable oxygen generator designed to deliver concentrated oxygen from ambient air for respiratory therapy. It operates by filtering and compressing atmospheric air to produce a high-flow oxygen output, typically used in clinical and homecare settings for patients requiring supplemental oxygen therapy.

This device is supplied as a reusable medical instrument, intended for use in hospital or home environments. It is classified as a Class II device under FDA regulations (868.5440) and has received FDA 510(k) clearance (K072348) as substantially equivalent to a predicate device. Multiple model variants are registered, including those with FEI numbers such as 3010440667 and others, ensuring compliance with regulatory standards for portable oxygen delivery systems.

Frequently asked questions

Is the Precision Oxygen Concentrator designed for single-use or can it be reused in clinical settings?

The Precision Oxygen Concentrator is explicitly described as a reusable medical instrument, intended for use in both hospital and homecare environments. Since it is classified as a reusable device, it must be properly cleaned, maintained, and serviced according to manufacturer guidelines to ensure safety and functionality for repeated use.

What types of environments is this device intended for, and how does its portability factor into its use?

The Precision Oxygen Concentrator is designed for portable oxygen delivery in both clinical (hospital) and homecare settings. Its portability allows it to be used where traditional oxygen tanks may be impractical, such as in patient homes or during patient transport, while still providing concentrated oxygen from ambient air.

How many model variants of this device are registered, and what does this indicate about customization or regulatory compliance?

Multiple model variants are registered under the Precision Oxygen Concentrator, with over 60 distinct FEI numbers listed. This suggests the device may offer different configurations or specifications to meet varying clinical or patient needs, while all variants remain compliant with FDA regulatory standards for portable oxygen generators (e.g., Class II, 510(k) clearance).

Does the device require any special handling or storage conditions, and is sterility a concern for reusable models?

Since the Precision Oxygen Concentrator is reusable, sterility is not an inherent requirement for its core function (as it generates oxygen from ambient air rather than delivering pre-packaged gas). However, reusable components that come into contact with patients—such as user interfaces or tubing attachments—must be cleaned and disinfected per manufacturer instructions to prevent contamination. Storage should follow guidelines to protect against environmental damage (e.g., moisture, dust).

What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

The Precision Oxygen Concentrator received FDA 510(k) clearance (K072348) under an *Abbreviated* pathway, determined to be *substantially equivalent* to a predicate device. This means it underwent a streamlined review process to demonstrate safety and effectiveness for its intended use—delivering concentrated oxygen from ambient air—without requiring full clinical trials. Clinically, this clearance ensures it meets FDA standards for portable oxygen generators (Class II, product code CAW), validating its use in both hospital and homecare respiratory therapy.

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: Precision Medical Oxygen Concentrators - New, Used & Refurbished ..., Oxygen concentrators | Precision Medical, PDF Portable Oxygen Concentrator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Precision Medical, Inc.

Sources (1)

  • FDA 510(k) K072348 24 fields · synced Sep 19, 2026