Cleared Special

K992672 - BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)

K992672 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 14-day FDA review.

K992672 · Belmont Instrument Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
14d
Days
Class 2
Risk

K992672 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 August 24, 1999 after a review of 14 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 - K992672

510(k) Number K992672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date August 24, 1999
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 K992672.
IRRIGATION OR INFUSION PUMP K PUMP
K991203 · Kmi Kolster Methods, Inc. · Oct 1999
INFUSION DYNAMICS POWER INFUSER MODEL M100B
K992044 · Infusion Dynamics, Inc. · Sep 1999
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
K991437 · Wells Johnson Co. · Aug 1999
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
K991275 · Mckinley, Inc. · Jul 1999
MINIMED 407C INFUSION PUMP, MODEL 407C
K991013 · Medtronic Minimed · Jun 1999
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
K991363 · Sorenson Medical, Inc. · May 1999