Cleared Traditional

Portable oxygen concentrator (JLO-190P)

K252616 · Shenzhen Homed Medical Device Co., Ltd. · Anesthesiology
Dec 2025
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K252616 is an FDA 510(k) clearance for the Portable oxygen concentrator (JLO-190P), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Shenzhen Homed Medical Device Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 22, 2025, 125 days after receiving the submission on August 19, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K252616 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2025
Decision Date December 22, 2025
Days to Decision 125 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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