Cleared Traditional

G1B PULSE OXIMETER (K082789) - FDA 510(k) Clearance

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

K082789 · General Meditech, Inc. · Anesthesiology device
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Jan 2009
Decision
106d
Days
Class 2
Risk

K082789 is an FDA 510(k) clearance for the G1B PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by General Meditech, Inc. (Shanghai, CN). The FDA issued a Cleared decision on January 7, 2009 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 General Meditech, Inc. devices

Submission Details

510(k) Number K082789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2008
Decision Date January 07, 2009
Days to Decision 106 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 140d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 240
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K082789.
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K081659 · Masimo Corporation · Sep 2008
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K080238 · Masimo Corporation · May 2008