Cleared Traditional

K213825 - Oxygen Concentrator model 8F-3A

K213825 is an FDA 510(k) clearance for Oxygen Concentrator model 8F-3A, manufactured by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 506-day FDA review.

K213825 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology device
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Apr 2023
Decision
506d
Days
Class 2
Risk

K213825 is an FDA 510(k) clearance for the Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on April 28, 2023 after a review of 506 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. devices

FDA 510(k) Submission Details - K213825

510(k) Number K213825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2021
Decision Date April 28, 2023
Days to Decision 506 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
366d slower than avg
Panel avg: 140d · This submission: 506d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K213825.
Inogen Rove 6
K230052 · Inogen, Inc. · Jun 2023
Portable Oxygen Concentrator (Model: P2-E7, P2-E)
K223379 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Jun 2023
Oxus Sieve Beds
K211056 · Oxus, Inc. · May 2023
Inogen Rove 4 Portable Oxygen Concentrator
K222086 · Inogen · Dec 2022
Oxygen Concentrator, Model JAY-5AW
K213210 · Longfian Scitech Co., Ltd. · Dec 2022
Portable Oxygen Concentrator, model: P2-E6
K210371 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Jun 2022