Class Class II
ARC Intensive Care Information System (ARC System) (K220117)
Description
ARC Intensive Care Information System (ARC System) by Ordinatrum Solutions, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220117
Clearance Date2023-06-06
Clearance TypeTraditional
Product CodeMWI
Regulation Number870.2300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220117
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. ARC Intensive Care Information System (ARC System) (K220117) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, ... | Magnus Medical, Inc. | 2022 |
| K142106 | DECISIO HEALTH PATIENT DASHBOARD | Decisio Health, Inc. | 2015 |
| K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | Edwards Lifesciences, LLC | 2015 |
Trace the full predicate network for K220117
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.