Cleared Traditional

Portable oxygen concentrator (JAY-1000P)

K243833 · Longfian Scitech Co., Ltd. · Anesthesiology
Sep 2025
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K243833 is an FDA 510(k) clearance for the Portable oxygen concentrator (JAY-1000P), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Longfian Scitech Co., Ltd. (Baoding, CN). The FDA issued a Cleared decision on September 29, 2025, 290 days after receiving the submission on December 13, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K243833 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2024
Decision Date September 29, 2025
Days to Decision 290 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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