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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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Catalogue (219)

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Device	Model / Reference	Registries	Class	Status
Buddy Lite, Battery Housing And Heater Unit, Sweden	905-00038	FDA UDI	Class II	Unknown
CureWrap™ Pediatric 122–135cm (single)	500-03548	FDA UDI	Class II	Active
Chinese, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-C	FDA UDI	Class II	Unknown
German, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-G	FDA UDI	Class II	Unknown
ThermoWrap™ Infant, 7.0–11Kg, (single)	500-03125	FDA UDI	Class II	Active
Italian, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-I	FDA UDI	Class II	Unknown
4.4 Liter Reservoir	902-00034	FDA UDI	Class II	Active
Hyperthermia Pump St In/Bifurcated Out Pt Line	902-00009P	FDA UDI	Class II	Unknown
buddy™ Disposable Set	905-00010	FDA UDI	Class II	Active
Acc. Kit for Infant with Reusable Temperature Sensor	200-00320	FDA UDI	N/A	Active
buddy, 230V SYSTEM	905-00001A-G-SW	FDA UDI	Class II	Unknown
Australian, Rapid Infuser, 230 V, 1000ml/min	903-00024-AUS	FDA UDI	Class II	Unknown
Dutch, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-D	FDA UDI	Class II	Unknown
buddy 2 SYSTEM	905-00037-E	FDA UDI	Class II	Unknown
Hyperthermia Pump Procedure Kit	902-00045	FDA UDI	Class II	Active
Acc. Kit for Adult with Interface Cables Only for Disposable Sensors	200-00310	FDA UDI	N/A	Active
Fluid Replacement Supply	903-00007P	FDA UDI	Class II	Unknown
buddy 2 Power Module	403-00413	FDA UDI	Class II	Unknown
Hyperthermia Pump Y-Set Pt Line	902-00004P	FDA UDI	Class II	Unknown
CureWrap™	Pediatric 79-91cm (single)	FDA UDI	Class II	Unknown
buddy™ Disposable Set	905-00010A	FDA UDI	Class II	Active
CureWrap™	Infant 7-21Kg (single)	FDA UDI	Class II	Unknown
Hyperthermia Pump Cannula Connector	902-00036	FDA UDI	Class II	Active
buddy, 230V SYSTEM	905-00001A-E-IR	FDA UDI	Class II	Unknown
Hyperthermia Pump Cannula Connector	902-00036P	FDA UDI	Class II	Unknown
CureWrap™	Infant 4-7Kg (single)	FDA UDI	Class II	Unknown
Chinese, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-C	FDA UDI	Class II	Unknown
Hyperthermia Pump St In/Bifurcated Out Pt Line Kit w/ 3L Reservoir	902-00008	FDA UDI	Class II	Unknown
buddy, Power Module	403-00231A	FDA UDI	Class II	Unknown
Hyperthermia Pump Accessory	902-00015	FDA UDI	Class II	Unknown
ThermoWrap™ Infant, 4.0–7.0Kg, (single)	500-03121	FDA UDI	Class II	Active
English, Rapid Infuser, 230 V, 750ml/min	903-00001A	FDA UDI	Class II	Unknown
Italian, Hyperthermia Pump, 230V	902-00001A-I	FDA UDI	Class II	Unknown
Buddy Lite	403-00340	FDA UDI	Class II	Unknown
buddy, 230V SYSTEM	905-00001A-E-SW	FDA UDI	Class II	Unknown
CureWrap™	Pediatric 122-135cm (single )	FDA UDI	Class II	Unknown
buddy 2 SYSTEM	905-00037-G	FDA UDI	Class II	Unknown
Hyperthermia Pump Thoracic Catheter	902-00043P	FDA UDI	Class II	Unknown
Japanese, Rapid Infuser, 100 V, 750 Ml/Min	903-00001-J	FDA UDI	Class II	Unknown
CureWrap™	Pediatric 104-122 cm (single)	FDA UDI	Class II	Unknown
CureWrap™ Infant, 4-7Kg (single)	500-03521	FDA UDI	Class II	Active
Buddy Lite, Battery Housing And Heater Unit, North America Military	905-00017B	FDA UDI	Class II	Unknown
Hyperthermia Pump Y-Set Pt Line Kit, w/ (2) 4.4L Reservoir	902-00046	FDA UDI	Class II	Unknown
CureWrap™ Pediatric, 79-91cm (8 pack)	500-03531	FDA UDI	Class II	Active
French, Rapid Infuser, 230 V, 750ml/min	903-00001A-F	FDA UDI	Class II	Unknown
Acc. Kit for Adult with Reusable Temperature Sensor	200-00300	FDA UDI	N/A	Active
Swedish, Rapid Infuser RI-2, 230V, 750 ml/min	903-00039A-SW	FDA UDI	Class II	Unknown
Buddy Lite, Battery Housing And Heater Unit, Germany	905-00016-G	FDA UDI	Class II	Unknown
Portuguese, Rapid Infuser RI-2, 230V, 1000 ml/min	903-00037A-P	FDA UDI	Class II	Unknown
Spanish, Hyperthermia Pump, 230V	902-00001A-S	FDA UDI	Class II	Unknown

Related Companies

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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.