Cleared Traditional

K142291 - GMX Series Medical Air/Oxygen Blender

K142291 is an FDA 510(k) clearance for GMX Series Medical Air/Oxygen Blender, manufactured by Gentec (Shanghai) Corporation. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K142291 · Gentec (Shanghai) Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
274d
Days
Class 2
Risk

K142291 is an FDA 510(k) clearance for the GMX Series Medical Air/Oxygen Blender. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Gentec (Shanghai) Corporation (Songjiang District, CN). The FDA issued a Cleared decision on May 19, 2015 after a review of 274 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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 - K142291

510(k) Number K142291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2014
Decision Date May 19, 2015
Days to Decision 274 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
134d slower than avg
Panel avg: 140d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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

Guangzhou Osmunda Medical Device Consulting Co., Ltd.
Mike Gu

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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 47
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K142291.
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