ABL90 FLEX PLUS— 510(k) K160153

Clearance details

Applicant

Radiometer Medical Aps

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2016-01-22

Decision date

2016-11-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Broenshoej, DK

• K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
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• 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

• K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX2017-09-21
• K170882 — ABL90 FLEX, ABL90 FLEX PLUS2017-04-28
• K142898 — ABL800 FLEX with AQURE connectivity2015-06-17
• K150226 — Hematocrit and Metabolite QUALICHECK2015-05-13
• K132691 — ABL90 FLEX2014-11-13

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-1659-2025 — Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.Class II·Ongoing·Radiometer Medical ApS·20250321
• Z-1857-2021 — Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.Class II·Ongoing·Radiometer Medical ApS·20210414
• Z-1858-2021 — E3800 PC Units (spare parts)Class II·Ongoing·Radiometer Medical ApS·20210414
• Z-1761-2020 — ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.Class II·Terminated·Radiometer Medical ApS·20200203
• Z-2138-2020 — ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are 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 setting.Class II·Terminated·Radiometer Medical ApS·20191121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160153.