Cleared Special

K091855 - THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000

K091855 is an FDA 510(k) clearance for THE BELMONT FLUID MANAGEMENT SYSTEM/ TH..., 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 8-day FDA review.

K091855 · Belmont Instrument Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
8d
Days
Class 2
Risk

K091855 is an FDA 510(k) clearance for the THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL 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 July 1, 2009 after a review of 8 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.

FDA 510(k) Submission Details - K091855

510(k) Number K091855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date July 01, 2009
Days to Decision 8 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
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 727
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K091855.
MICROFUSE DUAL RATE INFUSER
K091386 · Numia Medical Technology, LLC · Oct 2009
ALARIS PC UNIT, MODELS 8000 AND 8015
K091308 · Cardinal Health 303,Inc. · Jul 2009
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K083689 · B.Braun Medical, Inc. · Jul 2009
POWER INFUSER, MODEL M100B-3A
K090736 · ZOLL Medical Corporation · May 2009
CRONO S-PID 50
K091042 · Cane S.R.L. · May 2009
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
K090087 · Iradimed Corporation · Apr 2009
K091855 · THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
Download PDF Belmont Instrument Co…