Cleared Traditional

K171129 - CO Check Pro, CO Screen

K171129 is an FDA 510(k) clearance for CO Check Pro, manufactured by MD Diagnostics Limited. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K171129 · MD Diagnostics Limited · Anesthesiology device
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Mar 2018
Decision
319d
Days
Class 2
Risk

K171129 is an FDA 510(k) clearance for the CO Check Pro, CO Screen. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by MD Diagnostics Limited (Maidstone, GB). The FDA issued a Cleared decision on March 2, 2018 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all MD Diagnostics Limited devices

FDA 510(k) Submission Details - K171129

510(k) Number K171129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date March 02, 2018
Days to Decision 319 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
179d slower than avg
Panel avg: 140d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 21
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K171129.
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Pivot Breath Sensor
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ToxCO
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Carbon Monoxide Breath Sensor System (COBSS)
K171408 · Carrot Sense, Inc. · Sep 2017
CoSense ETCO Monitor
K151107 · Capnia, Inc. · Jul 2015
COSENSE CO MONITOR
K130036 · Capnia, Inc. · Jan 2014