Cleared Traditional

K060065 - CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

K060065 is an FDA 510(k) clearance for CAPNOSTREAM20 TWO PARAMETER BEDSIDE MON..., 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 115-day FDA review.

K060065 · Oridion Capnography, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
115d
Days
Class 2
Risk

K060065 is an FDA 510(k) clearance for the CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BED.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Oridion Capnography, Inc. (Jerusalem, IL). The FDA issued a Cleared decision on May 4, 2006 after a review of 115 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.

FDA 510(k) Submission Details - K060065

510(k) Number K060065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2006
Decision Date May 04, 2006
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
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.

Regulatory Peers - DQA Oximeter

All 686
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