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
Radiometer's ABL90 FLEX PLUS System is cleared here together with safeCLINITUBES. Product code CHL covers electrode-based measurement of blood gases (pCO2 and pO2) and blood pH. The record doesn't describe what safeCLINITUBES are.
Class II, 21 CFR 862.1120. The Clinical Chemistry panel reviewed it as a Traditional 510(k).
Radiometer Medical filed from Brønshøj, Denmark. Review took 270 days (July 14, 2025 to April 10, 2026).
Clearance details
- Applicant
- Radiometer Medicals Aps
- Product code
- Product 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.