Cleared Special

K983975 - BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

K983975 is the FDA 510(k) clearance for BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) by Belmont Instrument Corp.. It is a Class 2 General Hospital device (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)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 310
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K983975.
ACCLAIM INFUSION PUMP
K991501 · Abbott Laboratories · May 1999
PERFUSOR COMPACT
K983005 · B.Braun Medical, Inc. · Feb 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · Abbott Laboratories · Mar 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · Smith & Nephew, Inc. · Mar 1998