Cleared Special

K983975 - BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

K983975 is an FDA 510(k) clearance for BELMONT FLUID MANAGEMENT SYSTEM (FMS2000), manufactured by Belmont Instrument Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 21-day FDA review.

K983975 · Belmont Instrument Corp. · General Hospital
Download Printable Device Report (PDF)
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Nov 1998
Decision
21d
Days
Class 2
Risk

K983975 is an FDA 510(k) clearance for the BELMONT FLUID MANAGEMENT SYSTEM (FMS2000). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Belmont Instrument Corp. (Billerica, US). The FDA issued a Cleared decision on November 30, 1998 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Belmont Instrument Corp. devices

FDA 510(k) Submission Details - K983975

510(k) Number K983975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date November 30, 1998
Days to Decision 21 days
Submission Type Special
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
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 541
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K983975.
MELODIE INFUSION PUMP
K980378 · Compagnie DE Developpement Aguettant · Dec 1998
CUE AMBULATORY VOLUMETRIC INFUSION PUMP
K981816 · Becton Dickinson Curlin, LLC · Dec 1998
FLUIDSENSE FLUID DELIVERY SYSTEM
K982170 · Fluidsense Corp. · Nov 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · Sims Deltec, Inc. · Nov 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · Sims Deltec, Inc. · Nov 1998