FDA applicant
Bearpac Medical
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
How often FDA has decided Bearpac Medical’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2019high 1 (2019) · low 0 (2021)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Bearpac Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report