FDA applicant
Proact, Ltd.
FDA records 7 decisions for Proact, Ltd. (State College, PA) from 1990 to 2006: 7 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and LWE (Bone Marrow Collection/Transfusion Kit). Its devices cite 1 predicate, 1 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Proact, Inc.”, “Proact Co.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Proact, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Proact, Ltd. since 2007.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Proact, Ltd.’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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