FDA applicant

Puricore, Inc.

Malvern, PA10 decisions2006–20150 recalls

FDA records 10 decisions for Puricore, Inc. (Malvern, PA) from 2006 to 2015: 10 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and MED (Sterilant, Medical Devices). Its devices cite 29 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2015

2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Puricore, Inc.’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

Puricore, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?