ABL90 FLEX PLUS System— 510(k) K252488

Name: FDA 510(k) clearance K252488
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Substantially Equivalent

Radiometer Medicals Aps

FDA 510(k) clearance K252488 for ABL90 FLEX PLUS System, Substantially Equivalent on 2026-05-01. Applicant: Radiometer Medicals Aps. Device class: 2.

Clearance details

Applicant: Radiometer Medicals Aps
Product code: Code CGA
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2025-08-08
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brønshøj, DK

Download summary PDF View on FDA.gov ↗

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More clearances from Radiometer Medicals Aps

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K252475 — ABL90 FLEX PLUS System2026-05-01
K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
K241037 — ABL90 FLEX PLUS System2025-01-14
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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.