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FDA 510(k)

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

K-Number: K242660 · 2024-10-03

ApplicantZevex, Inc.
Decision Date2024-10-03
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is a medical device manufactured by Zevex, Inc.. It received FDA 510(k) clearance on 2024-10-03 under approval number K242660. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets?

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is a medical device that received FDA 510(k) clearance on 2024-10-03. It is manufactured by Zevex, Inc.. The 510(k) number is K242660.

When was Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets approved by the FDA?

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets received FDA 510(k) clearance on 2024-10-03, under approval number K242660.

What company makes Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets?

Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is manufactured by Zevex, Inc..

What is the FDA product code for Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets?

The FDA product code for Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets is FRN.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026)

Other Devices by Zevex, Inc.

K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

Related Devices (Code: FRN)

K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. K161667Sapphire Infusion PumpQ Core Medical , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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