Cleared Traditional

K071608 - A&J POCA01 OXYGEN CONCENTRATOR

K071608 is an FDA 510(k) clearance for A&J POCA01 OXYGEN CONCENTRATOR, manufactured by Zhongshan A&J Medical Equipment Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K071608 · Zhongshan A&J Medical Equipment Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
213d
Days
Class 2
Risk

K071608 is an FDA 510(k) clearance for the A&J POCA01 OXYGEN CONCENTRATOR. 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 Zhongshan A&J Medical Equipment Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on January 11, 2008 after a review of 213 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.

FDA 510(k) Submission Details - K071608

510(k) Number K071608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2007
Decision Date January 11, 2008
Days to Decision 213 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 140d · This submission: 213d
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 Consultant

Underwriters Laboratories, Inc.
MICHELLE S LEE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 284
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K071608.
HOMELOX
K081206 · Respironics, Inc. · Jul 2008
OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS
K080082 · Oxlife, LLC · Apr 2008
DRIVE SOLSTICE OXYGEN CONCENTRATOR
K080391 · Medical Depot · Mar 2008
LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
K072688 · International Biophysics Corp. · Jan 2008
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
K073242 · Delphi Medical Systems · Jan 2008
THE INVACARE FLYER, MODEL IPC 100
K071928 · Invacare Corp. · Dec 2007
K071608 · A&J POCA01 OXYGEN CONCENTRATOR
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