Class Class II
Anivia SG1000 Pump Console (K221491)
Description
Anivia SG1000 Pump Console by Apmtd, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221491
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeDWA
Regulation Number870.4380
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221491
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. Anivia SG1000 Pump Console (K221491) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131964 | BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE | Medtronic, Inc. | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232788 | INSPIRA ART100 | Inspira Technologies Oxy B.H.N. , Ltd. | 2024 |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | 2023 |
Trace the full predicate network for K221491
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.