510(k) Report

FDA applicant

Belmont Instrument Corp.

Billerica, MA22 decisions1981–20154 recalls

FDA records 22 decisions for Belmont Instrument Corp. (Billerica, MA) from 1981 to 2015: 22 510(k) clearances. Most are in product codes LGZ (Warmer, Thermal, Infusion Fluid) and BSB (Warmer, Blood, Non-Electromagnetic Radiation). Its devices cite 13 predicates, 11 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Belmont Instrument Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Belmont Instrument Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12009: 32011: 12013: 12014: 12015: 1
2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2025

2012: 12025: 3
2007high 3 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Belmont Instrument Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Belmont Instrument Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LGZWarmer, Thermal, Infusion Fluid6decisions
  • BSBWarmer, Blood, Non-Electromagnetic Radiation5decisions
  • FRNPump, Infusion5decisions
  • DSPSystem, Balloon, Intra-Aortic And Control5decisions
  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 13 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K972284Fluid Management SystemBelmont Instrument Corp. · 19976cite it
  • K070654Hyperthermia PumpBelmont Instrument Corp. · 20074cite it
  • K983866Belmont Model Ngpbp Intra-Aortic Balloon PumpBelmont Instrument Corp. · 20003cite it
  • K915580Belmont Model PBP Intra-Aortic Balloon PumpBelmont Instrument Corp. · 19922cite it
  • K992672Belmont Fluid Management System (FMS2000)Belmont Instrument Corp. · 19992cite it
  • K141654The Belmont Rapid InfuserBelmont Instrument Corporation · 20142cite it

What has FDA decided for it lately?

  • K152208The Belmont Hyperthermia PumpBelmont Instrument Corporation · 20153 recalls
  • K141654The Belmont Rapid InfuserBelmont Instrument Corporation · 2014
  • K131519Belmont Hyperthermia PumpBelmont Instrument Corp. · 2013
  • K112639The Belmont Buddy Lite Fluid WarmerBelmont Instrument Corp. · 2011
  • K091855The Belmont Fluid Management System/ the Belmont Rapid Infuser, Model FMS2000Belmont Instrument Corp. · 20091 recall
  • K090508The Belmont Buddy Lite Fluid WarmerBelmont Instrument Corp. · 2009
  • K090089Belmont Hyperthermia PumpBelmont Instrument Corp. · 2009
  • K070654Hyperthermia PumpBelmont Instrument Corp. · 2007

All 20 as Belmont Instrument Corp. →All 2 as Belmont Instrument Corporation →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K152208Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile…Mar 31, 2025Class II
  • K152208Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use…Mar 31, 2025Class II
  • K152208Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use…Mar 31, 2025Class II
  • K032674Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.Sep 25, 2012Class II

Other applicant names beginning “Belmont”

FDA records each applicant name separately; these may or may not be the same firm.

Belmont Equipment Corp. 12Belmont Medical Technologies 1