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Belmont Instrument Corp.

Last updated May 23, 2026

What Belmont Instrument Corp. makes

Belmont Instrument Corp. manufactures medical devices for temperature regulation and fluid warming, including external circulating-fluid control units for heating and cooling, heat-exchanging intravenous sets, and extracorporeal hyperthermia applicators. Their portfolio also includes warming pumps for high-flow infusions, conduction blood/fluid warmers, and disposable or reusable temperature-sensing kits for adult and infant patients. Specific products include reusable and disposable warming blankets (e.g., ThermoWrap™), intravenous line kits, and a rapid infusion pump designed for high-volume fluid administration.

All listed devices fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) or unique device identification (UDI) compliance. The company’s products are registered with the FDA under these pathways, and the manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What medical devices does Belmont Instrument Corp. manufacture?

Belmont Instrument Corp. manufactures medical devices for temperature regulation and fluid warming, including external circulating-fluid control units, heat-exchanging intravenous sets, extracorporeal hyperthermia applicators, warming pumps for high-flow infusions, conduction blood/fluid warmers, and disposable or reusable temperature-sensing kits for adult and infant patients.

Where is Belmont Instrument Corp. based?

Belmont Instrument Corp. is based in the United States, as indicated by the country designation in the provided device data.

Which regulatory registries list Belmont Instrument Corp.'s devices?

Belmont Instrument Corp.'s devices are listed in the FDA 510(k) registry and the FDA Unique Device Identification (UDI) system, as specified in the device data.

How are Belmont Instrument Corp.'s devices classified?

All listed devices from Belmont Instrument Corp. fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) or unique device identification (UDI) compliance, as stated in the device data.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
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EUDAMED SRN: —
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Catalogue (219)

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Device	Model / Reference	Registries	Class	Status
Spanish, Rapid Infuser, 230 V, 750ml/min	903-00001A-S	FDA UDI	Class II	Unknown
Hyperthermia Pump Y-Set Pt Line, 4.4L Reservoir	902-00047P	FDA UDI	Class II	Unknown
CureWrap™ Pediatric 104–122cm (single)	500-03541	FDA UDI	Class II	Active
3.0 Liter Reservoir (1 Piece)	903-00018P	FDA UDI	Class II	Active
Chinese, Rapid Infuser, 230 V, 1000ml/min	903-00024-C	FDA UDI	Class II	Unknown
German, Rapid Infuser, 230 V, 1000ml/min	903-00024-G	FDA UDI	Class II	Unknown
Buddy Lite With Ac, Battery Housing And Heater Unit, European	905-00023	FDA UDI	Class II	Unknown
buddy, Power Module, 120	905-00003	FDA UDI	Class II	Unknown
Italian, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-I	FDA UDI	Class II	Unknown
CritiCool Mini	200-00336	FDA UDI	Class II	Active
Dual Patient Line (1 Piece)	903-00004P	FDA UDI	Class II	Active
buddy, 120V SYSTEM	905-00001-US-F	FDA UDI	Class II	Unknown
Italian, Rapid Infuser, 230 V, 750ml/min	903-00001A-I	FDA UDI	Class II	Unknown
CureWrap™ Adult Over 135 cm	500-03500	EUDAMEDFDA UDI	Class II	Active
ThermoWrap™ Universal 152-168cm (single)	500-03160	FDA UDI	Class II	Active
CureWrap™ Infant, 2.5-4Kg	500-03518	FDA UDI	Class II	Active
buddy, 230V SYSTEM	905-00001A-F-SW	FDA UDI	Class II	Unknown
Hyperthermia Pump St In/Out Pt Line	902-00039P	FDA UDI	Class II	Unknown
Chinese, Rapid Infuser, 230 V, 750ml/min	903-00001A-C	FDA UDI	Class II	Unknown
Swedish, Rapid Infuser, 230 V, 1000ml/min	903-00024-SW	FDA UDI	Class II	Unknown
UK, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-UK	FDA UDI	Class II	Unknown
Norwegian, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-N	FDA UDI	Class II	Unknown
Hyperthermia Pump Accessory Kit	902-00013	FDA UDI	Class II	Active
buddy, Power Module	403-00231	FDA UDI	Class II	Unknown
ThermoWrap™ Pediatric, 122–135cm, (single)	500-03148	FDA UDI	Class II	Active
Buddy Lite With Ac, Battery Housing And Heater Unit, Australia	905-00040	FDA UDI	Class II	Unknown
English, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A	FDA UDI	Class II	Unknown
German, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-G	FDA UDI	Class II	Unknown
buddy, Power Module, 230V	905-00003A	FDA UDI	Class II	Unknown
buddy 2 SYSTEM	905-00037-F	FDA UDI	Class II	Unknown
Spanish, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-S	FDA UDI	Class II	Unknown
Procedure Pack x1	902-00048P	FDA UDI	Class II	Active
buddy, 230V SYSTEM	905-00001A-G-SE	FDA UDI	Class II	Unknown
ThermoWrap™ Universal 135-152cm, (single)	500-03153	FDA UDI	Class II	Active
CureWrap™	Pediatric 91-104cm (single)	FDA UDI	Class II	Unknown
buddy, 230V SYSTEM	905-00001A-E-SE	FDA UDI	Class II	Unknown
Hyperthermia Pump Y-Set Pt Line Kit, w/ (2) 3L Reservoir	902-00005	FDA UDI	Class II	Unknown
CureWrap™ Infant, 7-11Kg, (single)	500-03525	FDA UDI	Class II	Active
Buddy Lite With Ac, Battery Housing And Heater Unit	403-00340AC	FDA UDI	Class II	Unknown
Rapid Infuser Accessory Kit	903-00013	FDA UDI	Class II	Active
The Belmont® Rapid Infuser FMS2000	903-00001	FDA UDI	Class II	Unknown
Buddy, Heater	403-00268	FDA UDI	Class II	Unknown
French, Hyperthermia Pump, 230V	902-00001A-F	FDA UDI	Class II	Unknown
Swedish, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-SW	FDA UDI	Class II	Unknown
buddy lite AC Blood/Fluid Warmer	905-00022	FDA UDI	Class II	Active
CureWrap™	Pediatric 104-122cm (single)	FDA UDI	Class II	Unknown
Norwegian, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-N	FDA UDI	Class II	Unknown
buddy 2 SYSTEM	905-00037-UK	FDA UDI	Class II	Unknown
buddy, 230V SYSTEM	905-00001A-F-SE	FDA UDI	Class II	Unknown
Spanish, Rapid Infuser, 230 V, 1000ml/min	903-00024-S	FDA UDI	Class II	Unknown

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Belmont Instrument Corp. has eight FDA recall records initiated between September 25, 2012, and May 13, 2025. The records include instances where the status is open, classified, or terminated. Reasons cited involve potential temperature control issues with the ThermoWrap patient wrap when alarms are disabled, leaks in connectors or sets during priming (affecting the Rapid Infuser or Allon device), premature pump failure causing a HALT 4 error, and a saline bag leak leading to an electrical flash near the power entry module.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
May 13, 2025	Z-1966-2025	—	open, classified	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.
Mar 31, 2025	Z-1674-2025	—	open, classified	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.
Mar 31, 2025	Z-1675-2025	—	open, classified	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.
Mar 31, 2025	Z-1676-2025	—	open, classified	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.
Mar 31, 2025	Z-1678-2025	—	open, classified	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.
Jan 2, 2025	Z-1099-2025	—	open, classified	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
Jul 20, 2021	Z-0153-2023	—	open, classified	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.
Sep 25, 2012	Z-0058-2013	—	terminated	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.