Company ยท US
Belmont Instrument Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2015. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2015 | K152208 | The Belmont Hyperthermia Pump Belmont Instrument Corporation | LGZ |
| Jul 18, 2014 | K141654 | THE BELMONT RAPID INFUSER Belmont Instrument Corporation | FRN |
| Nov 6, 2013 | K131519 | BELMONT HYPERTHERMIA PUMP Belmont Instrument Corp. | LGZ |
| Nov 16, 2011 | K112639 | THE BELMONT BUDDY LITE FLUID WARMER Belmont Instrument Corp. | BSB |
| Jul 1, 2009 | K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 Belmont Instrument Corp. | FRN |
| Mar 26, 2009 | K090508 | THE BELMONT BUDDY LITE FLUID WARMER Belmont Instrument Corp. | BSB |
| Feb 12, 2009 | K090089 | BELMONT HYPERTHERMIA PUMP Belmont Instrument Corp. | LGZ |
| Jun 8, 2007 | K070654 | HYPERTHERMIA PUMP Belmont Instrument Corp. | LGZ |
| Oct 19, 2006 | K062774 | BELMONT BUDDY PLUS FLUID WARMER Belmont Instrument Corp. | BSB |
| Oct 13, 2005 | K052547 | BELMONT BUDDY FLUID WARMER Belmont Instrument Corp. | BSB |
| Sep 22, 2003 | K032778 | LARGE VOLUME FLUID RESERVOIR Belmont Instrument Corp. | LGZ |
| Sep 16, 2003 | K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 Belmont Instrument Corp. | LGZ |
| Jul 2, 2003 | K031478 | MICROHEATER Belmont Instrument Corp. | BSB |
| Jan 6, 2000 | K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP Belmont Instrument Corp. | DSP |
| Aug 24, 1999 | K992672 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) Belmont Instrument Corp. | FRN |
| Nov 30, 1998 | K983975 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) Belmont Instrument Corp. | FRN |
| Oct 2, 1998 | K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP Belmont Instrument Corp. | DSP |
| Nov 13, 1997 | K972284 | FLUID MANAGEMENT SYSTEM Belmont Instrument Corp. | FRN |
| Dec 26, 1995 | K952576 | TRANSPORT CART Belmont Instrument Corp. | DSP |
| May 24, 1995 | K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) Belmont Instrument Corp. | DSP |
| Oct 30, 1992 | K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP Belmont Instrument Corp. | DSP |
| Jan 29, 1981 | K810104 | ECG ARRHYTHMIA STIMULATOR Belmont Instrument Corp. | DPS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2025 | Belmont Instrument LLC Allon 2001. Part Number: 200-00263 Open, Classified |
DWJ | K024128 |
| Apr 25, 2025 | Belmont Instrument LLC Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-000 Open, Classified |
LGZ | K152208 |
| Apr 25, 2025 | Belmont Instrument LLC 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032.
The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The Open, Classified |
LGZ | K242735 |
| Apr 25, 2025 | Belmont Instrument LLC Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037) Open, Classified |
LGZ | K152208 |
| Apr 25, 2025 | Belmont Instrument LLC Hyperthermia Pump Procedure Kit. Model Number: 902-00045.
Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Open, Classified |
LGZ | K152208 |
| Feb 4, 2025 | Belmont Instrument LLC Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids Open, Classified |
FRN | K242735 |
| Oct 31, 2022 | Belmont Instrument Corporation CritiCool, thermoregulation device Open, Classified |
DWJ | K083662 |
| Oct 12, 2012 | Belmont Instrument Corporation Belmont Rapid Infuser, a Fluid Management System,
Model FMS2000. Terminated |
FRN | K032674 K091855 +1 |