Cleared Special

K151856 - ABL80 FLEX CO-OX with AQURE connectivity

K151856 is the FDA 510(k) clearance for ABL80 FLEX CO-OX with AQURE connectivity by Sendx Medical, Inc.. It is a Class 2 Chemistry device (product code CHL) cleared through the Special 510(k) pathway after a 29-day FDA review.

K151856 · Sendx Medical, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Aug 2015
Decision
29d
Days
Class 2
Risk

K151856 is an FDA 510(k) clearance for the ABL80 FLEX CO-OX with AQURE connectivity. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Sendx Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on August 6, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry 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.

View all Sendx Medical, Inc. devices

Submission Details

510(k) Number K151856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2015
Decision Date August 06, 2015
Days to Decision 29 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

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