Cleared Traditional

K023820 - CO2 CLIP

K023820 is an FDA 510(k) clearance for CO2 CLIP, manufactured by Bregas AB. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K023820 · Bregas AB · Anesthesiology device
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May 2003
Decision
173d
Days
Class 2
Risk

K023820 is an FDA 510(k) clearance for the CO2 CLIP. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Bregas AB (Bromma, SE). The FDA issued a Cleared decision on May 7, 2003 after a review of 173 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 - K023820

510(k) Number K023820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date May 07, 2003
Days to Decision 173 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 140d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 306
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K023820.
ADVISOR, MODEL 9200
K030407 · Bci, Inc. · Aug 2003
STATCO2METER, MODEL 10-55372
K031814 · Mercury Medical · Aug 2003
MINI STATCO2 CO2 DETECTOR, MODEL 10-55371
K031411 · Mercury Medical · Jul 2003
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES
K023454 · Datex-Ohmeda · Apr 2003
GAS SAMPLING LINES
K023579 · Promedic, Inc. · Jan 2003
MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
K021576 · Mercury Medical · Nov 2002
K023820 · CO2 CLIP
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