Cleared Traditional

K083559 - YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B

K083559 is an FDA 510(k) clearance for YUYUE OXYGENMAX OXYGEN CONCENTRATOR, 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 276-day FDA review.

K083559 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology device
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Sep 2009
Decision
276d
Days
Class 2
Risk

K083559 is an FDA 510(k) clearance for the YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B. 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. (Potomac, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 276 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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

FDA 510(k) Submission Details - K083559

510(k) Number K083559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2008
Decision Date September 04, 2009
Days to Decision 276 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 140d · This submission: 276d
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 209
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K083559.
AXS-590 SERIES
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K091191 · Respironics Inc., Sleep & Home Respiratory Group · Oct 2009
OMNI 2 OXYGEN SYSTEM
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JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000
K090007 · Danyang Jumao Healthcare Equipment Co., Ltd. · Jul 2009
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · Invacare Corporation · May 2009