Cleared Traditional

K232793 - Curlin 8000 Ambulatory Infusion System

Also marketed or referenced as:
Enterprise Solution (ES) Software Curlin 380-Series Adminstration Sets

K232793 is an FDA 510(k) clearance for Curlin 8000 Ambulatory Infusion System, manufactured by Zevex, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K232793 · Zevex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
249d
Days
Class 2
Risk

K232793 is an FDA 510(k) clearance for the Curlin 8000 Ambulatory Infusion System. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Zevex, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 17, 2024 after a review of 249 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Zevex, Inc. devices

FDA 510(k) Submission Details - K232793

510(k) Number K232793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date May 17, 2024
Days to Decision 249 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 129d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K232793.
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min)
K242735 · Belmont Medical Technologies · Dec 2024
Curlin 8000 Ambulatory Infusion System
K242660 · Zevex, Inc. · Oct 2024
Novum IQ Syringe Pump (40800BAXUS)
K242390 · Baxter Healthcare Corporation · Sep 2024
Novum IQ Large Volume Pump
K211122 · Baxter Healthcare Corporation · Mar 2024
Freedom60 Infusion Pump
K231918 · Koru Medical Systems · Nov 2023
SAFIRA
K230083 · Medovate Limited · Oct 2023