510(k) Report

FDA applicant

Founders Science Group, LLC

Taunton, MA2 decisions2016–20170 recalls

FDA records 2 decisions for Founders Science Group, LLC (Taunton, MA) from 2016 to 2017: 2 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and FRO (Dressing, Wound, Drug). Its devices cite 2 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

How often FDA has decided Founders Science Group, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Founders Science Group, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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