# K232793: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Zevex, Inc.
- Decided: May 17, 2024 after 249 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: 4 generations back to K960826 (1996). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software, Smiths Medical Asd, Inc. (2013) Summary page 5.
- 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 5.

## Most influential descendants
- K242660: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (2024), 0 descendants of its own

## Indications for use
The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult patients. The CURLIN® 8000 is not intended for use on pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN® 8000 is not indicated for the delivery of cellular blood products. RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the CURLIN® 8000 Ambulatory Infusion Pump. CURLIN® Administration Sets are intended to be used with CURLIN® infusion pumps to deliver medication from a container to a patient.

Source page: https://510kreport.com/device/K232793
Methodology: https://510kreport.com/methodology