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Longfei LFY-I-5 Oxygen Concentrator

by Zhejiang Longfei Industrial Co., Ltd.

510(k) K033405

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033405 Date18 Oct 2005ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CAW
Device Class
Class II
Regulation
21 CFR Part 868.5440
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Longfei Lfy-I-5 Oxygen Concentrator is an electromechanical device designed to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air using a molecular sieve. It is a portable oxygen generator. The device is classified as a Generator, Oxygen, Portable.

The Longfei Lfy-I-5 Oxygen Concentrator is supplied for use in the home and is intended for patients who require supplemental oxygen. It has received FDA 510K clearance, with the regulation number 868.5440. The device is designed for use in anesthesiology and is registered with the FDA under the product code CAW.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Longfei LFY-I-5 Oxygen Concentrator used for?

    The Longfei LFY-I-5 Oxygen Concentrator is designed to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air using a molecular sieve. It is intended for home use by patients who require supplemental oxygen.

  • How is the Longfei LFY-I-5 Oxygen Concentrator supplied?

    The Longfei LFY-I-5 Oxygen Concentrator is supplied as a portable oxygen generator for use in the home setting. It is manufactured by Zhejiang Longfei Industrial Co., Ltd. and is designed for use in anesthesiology.

  • What is the regulatory status of the Longfei LFY-I-5 Oxygen Concentrator?

    The Longfei LFY-I-5 Oxygen Concentrator has received FDA 510K clearance with regulation number 868.5440. It is classified as a Generator, Oxygen, Portable and is registered with the FDA under the product code CAW.

  • Is the Longfei LFY-I-5 Oxygen Concentrator reusable or single-use?

    The device data does not specify whether the Longfei LFY-I-5 Oxygen Concentrator is designed for single-use or multiple uses. For specific information regarding reusability, please consult the manufacturer's instructions or contact Zhejiang Longfei Industrial Co., Ltd.