Cleared Traditional

K071165 - ISCALERT SENSOR SYSTEM

K071165 is an FDA 510(k) clearance for ISCALERT SENSOR SYSTEM, manufactured by Alertis Medical AS. The device is a Class 2 Anesthesiology device with product code CCC cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K071165 · Alertis Medical AS · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
195d
Days
Class 2
Risk

K071165 is an FDA 510(k) clearance for the ISCALERT SENSOR SYSTEM. Classified as Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (product code CCC), Class II - Special Controls.

Submitted by Alertis Medical AS (Findley, US). The FDA issued a Cleared decision on November 7, 2007 after a review of 195 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1150 - 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 - K071165

510(k) Number K071165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2007
Decision Date November 07, 2007
Days to Decision 195 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
55d slower than avg
Panel avg: 140d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCC Device Classification - Class 2, Special Controls

Product Code CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1150
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 - CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

All 14
Devices cleared under the same product code (CCC) and FDA review panel - the closest regulatory comparables to K071165.
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K963935 · Optical Sensors, Inc. · Jan 1997
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
K951094 · Optical Sensors, Inc. · Jan 1996
K071165 · ISCALERT SENSOR SYSTEM
Download PDF FDA Summary Alertis Medical AS