ABL90 FLEX PLUS System, safeCLINITUBES— 510(k) K252207
Substantially EquivalentRadiometer Medicals Aps
FDA 510(k) clearance K252207 for ABL90 FLEX PLUS System, safeCLINITUBES, Substantially Equivalent on 2026-04-10. Applicant: Radiometer Medicals Aps. Device class: 2.
Summary
The ABL90 FLEX PLUS is Radiometer's blood gas analyzer, and this clearance pairs it with safeCLINITUBES, the company's capillary sampling tubes. Product code CHL covers electrode-based measurement of blood gases (pCO2 and pO2) and blood pH.
Class II, 21 CFR 862.1120. The Clinical Chemistry panel reviewed it as a Traditional 510(k).
Radiometer Medical filed from Brønshøj, Denmark, just outside Copenhagen. Review took 270 days (July 14, 2025 to April 10, 2026). The ABL90 line has been on the market for years, so this is more likely a system update or new sample-handling setup than a new analyzer.
Clearance details
- Applicant
- Radiometer Medicals Aps
- Product code
- Code CHL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1120
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brønshøj, DK
Recent devices under product code CHL
view allMore clearances from Radiometer Medicals Aps
view allAdverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
Source: openFDA MAUDE database, through . 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.