Belmont Instrument LLC
FDA Regulatory Profile
Belmont Instrument LLC appears in FDA public data with 6 recalls, 20 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1966-2025, Class II) was initiated on May 13, 2025. Its most recent 510(k) clearance was granted on November 6, 2013.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 20
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1966-2025 | Class II | Allon 2001. Part Number: 200-00263 | May 13, 2025 |
| Z-1678-2025 | Class II | 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of | March 31, 2025 |
| Z-1676-2025 | Class II | Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disp | March 31, 2025 |
| Z-1674-2025 | Class II | Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set u | March 31, 2025 |
| Z-1675-2025 | Class II | Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposa | March 31, 2025 |
| Z-1099-2025 | Class II | Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used | January 2, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131519 | BELMONT HYPERTHERMIA PUMP | November 6, 2013 |
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | November 16, 2011 |
| K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | July 1, 2009 |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | March 26, 2009 |
| K090089 | BELMONT HYPERTHERMIA PUMP | February 12, 2009 |
| K070654 | HYPERTHERMIA PUMP | June 8, 2007 |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | October 19, 2006 |
| K052547 | BELMONT BUDDY FLUID WARMER | October 13, 2005 |
| K032778 | LARGE VOLUME FLUID RESERVOIR | September 22, 2003 |
| K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | September 16, 2003 |
| K031478 | MICROHEATER | July 2, 2003 |
| K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP | January 6, 2000 |
| K992672 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | August 24, 1999 |
| K983975 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | November 30, 1998 |
| K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP | October 2, 1998 |
| K972284 | FLUID MANAGEMENT SYSTEM | November 13, 1997 |
| K952576 | TRANSPORT CART | December 26, 1995 |
| K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) | May 24, 1995 |
| K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP | October 30, 1992 |
| K810104 | ECG ARRHYTHMIA STIMULATOR | January 29, 1981 |