510(k) Report

FDA applicant

Bearpac Medical

Moultonborough, NH3 decisions2019–20230 recalls

FDA records 3 decisions for Bearpac Medical (Moultonborough, NH) from 2019 to 2023: 3 510(k) clearances. Most are in product codes DWM (Apparatus, Suction, Patient Care) and PNG (Peritoneal, Drainage Catheter For Refractory…). 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 Bearpac Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12020: 12023: 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Bearpac Medical by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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