510(k) Report

FDA applicant

Belmont Medical Technologies

Billerica, MA1 decision2024–20242 recalls

FDA records 1 decision for Belmont Medical Technologies (Billerica, MA) in 2024: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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 Medical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

2in 2025

2025: 2
2024high 2 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Belmont Medical Technologies by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Belmont”

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