ABL 80 CO-OX SYSTEM— 510(k) K080370

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

2008-02-12

Decision date

2008-07-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

• K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
• K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
• K240998 — ABL90 FLEX PLUS System2024-12-13
• K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
• K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

• K151639 — ABL80 FLEX and ABL80 FLEX CO-OX2015-12-07
• K151856 — ABL80 FLEX CO-OX with AQURE connectivity2015-08-06
• 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-2468-2020 — ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.Class II·Terminated·Radiometer Medical ApS·20200511
• Z-2304-2012 — ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.Class II·Terminated·Sendx Medical Inc·20120606
• Z-0195-2013 — ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care settingClass II·Terminated·Sendx Medical Inc·20100106

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080370.