Cleared Traditional

Portable Oxygen Concentrator (P2-TOC)

K242718 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Anesthesiology
Feb 2025
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K242718 is an FDA 510(k) clearance for the Portable Oxygen Concentrator (P2-TOC), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Qingdao Kingon Medical Science and Technology Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on February 28, 2025, 171 days after receiving the submission on September 10, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K242718 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2024
Decision Date February 28, 2025
Days to Decision 171 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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