Class Class II
Avoset Infusion Pump System (K213744)
Description
Avoset Infusion Pump System by Eitan Medical , Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213744
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeFRN
Regulation Number880.5725
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213744
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. Avoset Infusion Pump System (K213744) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical , Ltd. | 2020 |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communi... | Smiths Medical Ads, Inc. | 2017 |
Trace the full predicate network for K213744
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.