Cleared Traditional

K090007 - JUMAO OXYGEN CONCENTRATOR

K090007 is an FDA 510(k) clearance for JUMAO OXYGEN CONCENTRATOR, manufactured by Danyang Jumao Healthcare Equipment Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K090007 · Danyang Jumao Healthcare Equipment Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K090007

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
63d slower than avg
Panel avg: 140d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 121
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K090007.
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
K103563 · Precision Medical, Inc. · Jul 2011
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
K091716 · Merits Health Products Co., Ltd. · Apr 2010
GAS TRANSFILL
K091191 · Respironics Inc., Sleep & Home Respiratory Group · Oct 2009
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028 · Respironics, Inc. · Jul 2009
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
K083751 · Invacare Corporation · May 2009
PRECISION OXYGEN CONCENTRATOR
K072348 · Precision Medical, Inc. · Oct 2008