K252207
Substantially EquivalentABL90 FLEX PLUS System, safeCLINITUBES
The ABL90 FLEX PLUS with safeCLINITUBES is a benchtop blood gas, electrolyte, and metabolite analyzer with a sealed sample-handling accessory. Product code CHL covers clinical chemistry gas analyzers intended for point-of-care or near-patient use; Radiometer is the incumbent in this category and the ABL90 line is their flagship.
Clinical Chemistry panel, Traditional 510(k). The safeCLINITUBES add-on is a closed-tube sampling path — relevant for infection-control workflows in ICUs and EDs. The clearance likely reflects minor design updates or labeling changes to an already-cleared predicate in the ABL90 family rather than a novel analytic capability.
Radiometer (a Danaher subsidiary) files from Brønshøj, Denmark. CHL submissions from this applicant tend to cycle on a regular cadence as they manage the analyzer family across markets.
- Applicant
- Radiometer Medicals Aps
- Product code
- CHL
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brønshøj, DK
Adverse 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.