510(k) Report

FDA applicant

Biological Signal Processing, Ltd.

Somerset, MA5 decisions2005–20100 recalls

FDA records 5 decisions for Biological Signal Processing, Ltd. (Somerset, MA) from 2005 to 2010: 5 510(k) clearances. All are in product code MWI (Monitor, Physiological, Patient (Without…). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Biological Signal Processing, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 22008: 12010: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biological Signal Processing, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Biological”

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