Cleared Special

K072295 - CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE

K072295 is an FDA 510(k) clearance for CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGI..., manufactured by Oridion Capnography, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 56-day FDA review.

K072295 · Oridion Capnography, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
56d
Days
Class 2
Risk

K072295 is an FDA 510(k) clearance for the CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Oridion Capnography, Inc. (Jerusalem, IL). The FDA issued a Cleared decision on October 11, 2007 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072295

510(k) Number K072295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date October 11, 2007
Days to Decision 56 days
Submission Type Special
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
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K072295.
PM-60 PULSE OXIMETER
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MEDIAID PULSE OXIMETER M30 AND M34
K071610 · Mediaid, Inc. · Nov 2007
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
SENTEC DIGITAL MONITORING SYSTEM
K071672 · Sentec AG · Sep 2007
FINGERTIP PULSE OXIMETER MD300C
K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007