Class Class II
ABL90 FLEX PLUS System (K241037)
Description
ABL90 FLEX PLUS System by Radiometer Medicals Aps, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241037
Clearance Date2025-01-14
Clearance TypeTraditional
Product CodeCEM
Regulation Number862.1600
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241037
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ABL90 FLEX PLUS System (K241037) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K092686 | ABL90 FLEX SERIES | Radiometer Medical Aps | 2010 |
Trace the full predicate network for K241037
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.