Cleared Traditional

K981816 - CUE AMBULATORY VOLUMETRIC INFUSION PUMP

K981816 is an FDA 510(k) clearance for CUE AMBULATORY VOLUMETRIC INFUSION PUMP, manufactured by Becton Dickinson Curlin, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K981816 · Becton Dickinson Curlin, LLC · General Hospital
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Dec 1998
Decision
196d
Days
Class 2
Risk

K981816 is an FDA 510(k) clearance for the CUE AMBULATORY VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Becton Dickinson Curlin, LLC (Huntington Beach, US). The FDA issued a Cleared decision on December 4, 1998 after a review of 196 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 Becton Dickinson Curlin, LLC devices

FDA 510(k) Submission Details - K981816

510(k) Number K981816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date December 04, 1998
Days to Decision 196 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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 542
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K981816.
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
VARIABLE PRESSURE SYRINGE PUMP
K974332 · Alaris Medical Systems, Inc. · Dec 1998
MELODIE INFUSION PUMP
K980378 · Compagnie DE Developpement Aguettant · Dec 1998
FLUIDSENSE FLUID DELIVERY SYSTEM
K982170 · Fluidsense Corp. · Nov 1998
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K983975 · Belmont Instrument Corp. · Nov 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998