Cleared Traditional

Portable Oxygen Concentrator (Spirit-3)

K242736 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology
Jun 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K242736 is an FDA 510(k) clearance for the Portable Oxygen Concentrator (Spirit-3), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on June 5, 2025, 267 days after receiving the submission on September 11, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K242736 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2024
Decision Date June 05, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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