Cleared Traditional

K082268 - CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 140d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00659516 Unknown Observational

Smart Capnography Respiratory Index in Post Anesthesia Patients

Smart Capnography Respiratory Index: Clinical Evaluation

40
Patients (est.)
1
Site
Condition studied Patients After Surgery and Anesthesia Monitored in the PACU
Eligibility All sexes
Principal investigator Yaacov Gozal, MD
Sponsor Shaare Zedek Medical Center
Started 2008-05-01 → Primary completion 2008-08-01 → Completed 2008-12-01
Primary outcome
To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 686
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K082268.
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