Cleared Traditional

K082268 - CAPNOSTREAM20 WITH INTEGRATED PULMONARY...

K082268 is an FDA 510(k) clearance for CAPNOSTREAM20 WITH INTEGRATED PULMONARY..., manufactured by Oridion Capnography, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K082268 · Oridion Capnography, Inc. · Anesthesiology device
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Feb 2009
Decision
179d
Days
Class 2
Risk

K082268 is an FDA 510(k) clearance for the CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Oridion Capnography, Inc. (Jerusalem, IL). The FDA issued a Cleared decision on February 6, 2009 after a review of 179 days - an extended review cycle.

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 Oridion Capnography, Inc. devices

FDA 510(k) Submission Details - K082268

510(k) Number K082268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date February 06, 2009
Days to Decision 179 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
39d slower than avg
Panel avg: 140d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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.

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All 478
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