510(k) Report

FDA applicant

Boston Medical Products, Inc.

Westborough, MA33 decisions1980–20090 recalls

FDA records 33 decisions for Boston Medical Products, Inc. (Westborough, MA) from 1980 to 2009: 33 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and LYA (Splint, Intranasal Septal). Its devices cite 4 predicates, 0 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, ear, nose and throat panel, where it files most

How often FDA has decided Boston Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Boston Medical Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Boston Medical Products, Inc.’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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Other applicant names beginning “Boston”

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