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ABL80 FLEX CO-OX With AQURE Connectivity

by Sendx Medical, Inc.

510(k) K151856

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK151856 Date6 Aug 2015ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1582-2018 FDA Class II initiated 27 Feb 2018

    There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.

    • Terminated Z-0899-2017 FDA Class II initiated 23 Nov 2016

    Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

    • Terminated Z-0748-2016 FDA Class II initiated 29 Dec 2015

    The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to misinterpretation of results.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CHL
Device Class
Class II
Regulation
21 CFR Part 862.1120
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ABL80 FLEX CO-OX with AQURE connectivity is a portable, automated system designed for the in vitro testing of whole blood samples. It functions as an electrode measurement device for blood gases, including Pco2 and Po2, as well as blood pH.

This device is intended for use by trained technologists, nurses, physicians, and therapists in laboratory, near-patient, or point-of-care settings. It has received FDA 510(k) clearance and is manufactured by SenDx Medical, Inc.

Other devices from Sendx Medical, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the ABL80 FLEX CO-OX?

    The ABL80 FLEX CO-OX is an automated, portable system designed for in vitro testing of whole blood samples. It utilizes electrode measurement technology to analyze blood gases, specifically Pco2 and Po2, as well as blood pH.

  • Who is authorized to operate this blood gas analyzer?

    This device is intended for use by qualified healthcare professionals, including physicians, nurses, therapists, and trained technologists. It is suitable for operation in laboratory, point-of-care, or near-patient clinical settings.

  • What is the regulatory status of this device?

    The ABL80 FLEX CO-OX with AQURE connectivity has received FDA 510(k) clearance, confirming it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.