ABL80 FLEX CO-OX with AQURE connectivity— 510(k) K151856

Clearance details

Applicant

Sendx Medical, Inc.

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2015-07-08

Decision date

2015-08-06

Decision

Substantially Equivalent

Clearance type

Special

Location

Carlsbad, CA, US

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• K151639 — ABL80 FLEX and ABL80 FLEX CO-OX2015-12-07
• K080370 — ABL 80 CO-OX SYSTEM2008-07-31
• K051804 — ABL80 FLEX ANALYZER2005-11-01
• K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM2000-02-01
• K973742 — SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM1997-12-03

Death

20

Malfunction

999

Total

1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1582-2018 — AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets the user send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.Class II·Terminated·Radiometer Medical ApS·20180227
• Z-0899-2017 — AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.Class II·Terminated·Radiometer America Inc·20161123
• Z-0748-2016 — AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.Class II·Terminated·Radiometer America Inc·20151229

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151856.