FDA applicant
Integra Lifesciences Production Corporation
FDA records 9 decisions for Integra Lifesciences Production Corporation (Mansfield, MA) from 2021 to 2026: 9 510(k) clearances. Most are in product codes JXG (Shunt, Central Nervous System And Components) and GWM (Device, Monitoring, Intracranial Pressure). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 3 of them its own earlier devices. 6 recalls are linked to its devices, 2 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Integra Lifesciences Production Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
4in 2024
Class I Class II/III not classified
Planning a device like Integra Lifesciences Production…’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) ReportOther applicant names beginning “Integra”
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