Class Class II
Infinity CentralStation Wide (K240312)
Description
Infinity CentralStation Wide by Draeger Medical Systems, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240312
Clearance Date2024-08-01
Clearance TypeTraditional
Product CodeMHX
Regulation Number870.1025
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240312
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. Infinity CentralStation Wide (K240312) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023 |
Trace the full predicate network for K240312
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.