Data / Medical devices / United States / Belmont Medical Technologies
Belmont Medical Technologies: FDA-registered device maker in Billerica, MA, United States, 8 510(k) clearances
Belmont Medical Technologies is registered with the FDA (registration 1219702) in Billerica, MA, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 23, 2024. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1219702
- Address
- 780 Boston Rd, Billerica, MA, United States, 01821
- Owner or operator
- BELMONT INSTRUMENT LLC. (1219702)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- May 22, 2009
- Registered through
- 2026
- Brand names listed
- 3 Liter Disposable Set, 3 Liter Reservoir (1 Piece), 3 Liter Reservoir (6 Count), 3-Spike Disposable Set, 3-Spike Disposable Set (1 Piece), 4.4 Liter Reservoir, Allon 2001 ®, Buddy Lite Blood/Fluid Warmer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion | FRN | 2 | Manufacturer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | 2 | Manufacturer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | 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 | Belmont Medical Technologies | accessdata.fda.gov |
| September 2, 2015 | K152208 | The Belmont Hyperthermia Pump | LGZ | Substantially Equivalent | Belmont Instrument Corporation | accessdata.fda.gov |
| November 16, 2011 | K112639 | THE BELMONT BUDDY LITE FLUID WARMER | BSB | Substantially Equivalent | Belmont Instrument Corp. | accessdata.fda.gov |
| July 1, 2009 | K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | FRN | Substantially Equivalent | Belmont Instrument Corp. | accessdata.fda.gov |
| March 26, 2009 | K090508 | THE BELMONT BUDDY LITE FLUID WARMER | BSB | Substantially Equivalent | Belmont Instrument Corp. | accessdata.fda.gov |
| March 26, 2009 | K083662 | CRITICOOL | DWJ | Substantially Equivalent | Mtre Advanced Technology , Ltd. | accessdata.fda.gov |
| September 16, 2003 | K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | LGZ | Substantially Equivalent | Belmont Instrument Corp. | accessdata.fda.gov |
| February 10, 2003 | K024128 | ALLON 2001 VERSION 5 | DWJ | Substantially Equivalent | Mtre Advanced Technology , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 13, 2025 | 96854 | Class II | Ongoing | 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 | accessdata.fda.gov |
| March 31, 2025 | 96625 | Class II | Ongoing | 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 packa | 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. | accessdata.fda.gov |
| March 31, 2025 | 96617 | Class II | Ongoing | 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 902-00034 | 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. | accessdata.fda.gov |
| January 2, 2025 | 96092 | Class II | Ongoing | 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 | 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 | accessdata.fda.gov |
| July 20, 2021 | 90939 | Class II | Ongoing | 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. | accessdata.fda.gov |
| September 25, 2012 | 62703 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Thermal Regulating
- All makers of Warmer, Blood, Non-Electromagnetic Radiation
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Pump, Infusion
Updated June 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.