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Precision Portable Oxygen Concentration Model 4150

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103563

by Precision Medical, Inc.

Identifiers

510(k) Number
K103563 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 Portable Oxygen Concentrator Model 4150 is a portable oxygen generator designed to deliver supplemental oxygen therapy. Classified as a portable oxygen generator, it concentrates ambient air to produce and supply oxygen for patients requiring respiratory support, typically in clinical or home settings.

This device is intended for single-use or reusable applications in anesthesia and respiratory care environments. It operates as a Class II medical device under FDA 510(k) clearance (K103563) and is regulated under 21 CFR 868.5440. The unit is portable, designed for use in various settings including hospitals and patient homes, and requires proper storage and maintenance as specified in its instructions.

Frequently asked questions

What clinical settings is the Precision Portable Oxygen Concentrator Model 4150 intended for use in?

The Precision Portable Oxygen Concentrator Model 4150 is designed for use in both clinical environments like hospitals and home settings. It is specifically intended for delivering supplemental oxygen therapy to patients requiring respiratory support, making it versatile for anesthesia and respiratory care applications.

Is the Precision Portable Oxygen Concentrator Model 4150 intended for single-use or reusable applications?

The device is explicitly designed for both single-use and reusable applications in anesthesia and respiratory care environments. This flexibility allows it to be used in various settings where oxygen therapy is required, depending on facility protocols and patient needs.

How is the device regulated, and what does that mean for its use in healthcare facilities?

The Precision Portable Oxygen Concentrator Model 4150 is classified as a Class II medical device and has received FDA 510(k) clearance (K103563) under 21 CFR 868.5440. This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA safety and performance standards for portable oxygen generators. Facilities using it must follow manufacturer instructions for proper storage, maintenance, and operation to ensure compliance with regulatory requirements.

Does the device come in multiple sizes or models, and if so, how would I identify them?

The device data includes multiple FEI numbers (e.g., 3010440667, 3008507279, etc.), which correspond to different regulatory registrations for the Precision Portable Oxygen Concentrator Model 4150. While these numbers don’t specify physical size variations, they indicate different lots or configurations that may have been submitted for regulatory review. For exact sizing or model variations, refer to the manufacturer’s documentation or contact Precision Medical, Inc. directly, as the data does not detail specific size differences.

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: PDF Model: PM4150 Series - Precision Medical, Inc., Precision Medical PM4150 Portable Oxygen Concentrator User Manual, Precision Medical PM4150 User Manual - ManualMachine.com, Precision Medical EasyPulse POC PM4150 Series User Manual, Precision Portable Oxygen Concentration Model 4150

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) K103563 24 fields · synced Sep 19, 2026