Cleared Traditional

K090007 - JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090007 · Danyang Jumao Healthcare Equipment Co., Ltd. · Anesthesiology device
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Jul 2009
Decision
203d
Days
Class 2
Risk

K090007 is an FDA 510(k) clearance for the JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000. 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 Danyang Jumao Healthcare Equipment Co., Ltd. (Danyang City,Jiangsu Province, CN). The FDA issued a Cleared decision on July 24, 2009 after a review of 203 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 Danyang Jumao Healthcare Equipment Co., Ltd. devices

Submission Details

510(k) Number K090007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date July 24, 2009
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 139d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 284
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