Belmont Medical Technologies
Billerica, MA, US
BELMONT MEDICAL TECHNOLOGIES appears in FDA device records in Billerica, MA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Belmont Medical Technologies carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Belmont Instrument Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 23 510(k) clearances for Belmont Medical Technologies between 1981 and 2024. The busiest year on record is 2003, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1992 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 3 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 3 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) | FRN | Substantially Equivalent | |
| K152208 | The Belmont Hyperthermia Pump | LGZ | Substantially Equivalent | |
| K141654 | THE BELMONT RAPID INFUSER | FRN | Substantially Equivalent | |
| K131519 | BELMONT HYPERTHERMIA PUMP | LGZ | Substantially Equivalent | |
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | BSB | Substantially Equivalent | |
| K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | FRN | Substantially Equivalent | |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | BSB | Substantially Equivalent | |
| K090089 | BELMONT HYPERTHERMIA PUMP | LGZ | Substantially Equivalent | |
| K070654 | HYPERTHERMIA PUMP | LGZ | Substantially Equivalent | |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | BSB | Substantially Equivalent | |
| K052547 | BELMONT BUDDY FLUID WARMER | BSB | Substantially Equivalent | |
| K032778 | LARGE VOLUME FLUID RESERVOIR | LGZ | Substantially Equivalent | |
| K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | LGZ | Substantially Equivalent | |
| K031478 | MICROHEATER | BSB | Substantially Equivalent | |
| K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP | DSP | Substantially Equivalent | |
| K992672 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | FRN | Substantially Equivalent | |
| K983975 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | FRN | Substantially Equivalent | |
| K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP | DSP | Substantially Equivalent | |
| K972284 | FLUID MANAGEMENT SYSTEM | FRN | Substantially Equivalent - Subject to Tracking Reg. | |
| K952576 | TRANSPORT CART | DSP | Substantially Equivalent | |
| K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) | DSP | Substantially Equivalent | |
| K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP | DSP | Substantially Equivalent | |
| K810104 | ECG ARRHYTHMIA STIMULATOR | DPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219702 | 1219702 | BELMONT MEDICAL TECHNOLOGIES | 780 Boston Rd, BILLERICA, MA 01821 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1966-2025 | Allon 2001. Part Number: 200-00263 | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition. | Class II | Open, Classified | |
| Z-1676-2025 | 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 902-00038) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Bifurcated Outflow Patient Line (P/N 902-00040P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P). | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. | Class II | Open, Classified | |
| Z-1678-2025 | 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 two components are packaged separately in individual pouches and placed in the same case for shipment. The female quick connector that may be cracked is located on the Heat Exchanger/Patient Line set. | Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser. | Class II | Open, Classified | |
| Z-1675-2025 | 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) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and Straight Inflow/Outflow Patient Line (P/N 902-00039P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P). | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. | Class II | Open, Classified | |
| Z-1674-2025 | 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 Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP Procedure Pack (P/N 902-00048P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P). | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser. | Class II | Open, Classified | |
| Z-1099-2025 | 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 to any patients e10 kg requiring warmed infusion. Part Number:903-00006 | Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set | Class II | Open, Classified | |
| Z-0153-2023 | CritiCool, thermoregulation device | Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue. | Class II | Open, Classified | |
| Z-0058-2013 | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. | Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain