# K213744: Avoset Infusion Pump System

- Pathway: 510(k) (Traditional)
- Applicant: Eitan Medical, Ltd.
- Decided: Mar 10, 2023 after 466 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K904518 (1990). 30 ancestors in all.
No later device cites it as a predicate yet.
11 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170982: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM), Smiths Medical Ads, Inc. (2017) Summary page 4.
- K192860: Sapphire Infusion Pump, Sapphire administration sets, Q Core Medical, Ltd. (2020) Summary page 4.

## Indications for use
Intended use: The Avoset Infusion Pump is a single-channel, volumetric infusion pump. Medication is delivered at continuous rate, and/or with an intermittent bolus, and/or with a patient bolus and/or with taper. Indication of use: Routes: Parenteral (intra-arterial, intra-venous, subcutaneous, perineural, epidural) and enteral infusions Fluids: IV medication (including fluids), Total Parenteral Nutrition (TPN), enteral medication and nutrition, lipids, epidural medication. Program Types (specific uses): The pump delivers in one of four program types: a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled intermittent doses, and/or with tapering. Patient Population: Pediatric: infants, children, and adolescents and adult patients. Intended Environments. Intended to be used in clinical environment and ambulatory environment including, home, plane and ground transportation. Users: licensed health care professional and lay users The dedicated Administration Sets for the Avoset Infusion Pump are intended for single-patient use and single-use only. Set configurations are: (i) Enteral; (ii) Epidural and (iii) General purpose for the balance of the routes: intra-arterial, intra- venous, subcutaneous, perineural. The Avoset Programming Tool is intended to be used with a computer to create a treatment-based protocol that is loaded onto the pump. The programming tool is intended for use by professional users.

Source page: https://510kreport.com/device/K213744
Methodology: https://510kreport.com/methodology