Belmont Instrument LLC

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
20
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1966-2025Class IIAllon 2001. Part Number: 200-00263May 13, 2025
Z-1678-2025Class II3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists ofMarch 31, 2025
Z-1676-2025Class IIStraight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, dispMarch 31, 2025
Z-1674-2025Class IIHyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set uMarch 31, 2025
Z-1675-2025Class IIStraight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposaMarch 31, 2025
Z-1099-2025Class IIBelmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be usedJanuary 2, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K131519BELMONT HYPERTHERMIA PUMPNovember 6, 2013
K112639THE BELMONT BUDDY LITE FLUID WARMERNovember 16, 2011
K091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000July 1, 2009
K090508THE BELMONT BUDDY LITE FLUID WARMERMarch 26, 2009
K090089BELMONT HYPERTHERMIA PUMPFebruary 12, 2009
K070654HYPERTHERMIA PUMPJune 8, 2007
K062774BELMONT BUDDY PLUS FLUID WARMEROctober 19, 2006
K052547BELMONT BUDDY FLUID WARMEROctober 13, 2005
K032778LARGE VOLUME FLUID RESERVOIRSeptember 22, 2003
K032674BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000September 16, 2003
K031478MICROHEATERJuly 2, 2003
K983866BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMPJanuary 6, 2000
K992672BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)August 24, 1999
K983975BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)November 30, 1998
K982538BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABPOctober 2, 1998
K972284FLUID MANAGEMENT SYSTEMNovember 13, 1997
K952576TRANSPORT CARTDecember 26, 1995
K950687EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)May 24, 1995
K915580BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMPOctober 30, 1992
K810104ECG ARRHYTHMIA STIMULATORJanuary 29, 1981