FDA applicant
Belport Company, Inc., Gingi-Pak
FDA records 11 decisions for Belport Company, Inc., Gingi-Pak (Camarillo, CA) from 2020 to 2026: 11 510(k) clearances. Most are in product codes MVL (Cord, Retraction) and KLE (Agent, Tooth Bonding, Resin). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 151 for FDA’s reviews in the same codes and years. Its devices cite 5 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
How often FDA has decided Belport Company, Inc., Gingi-Pak’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Belport Company, Inc., Gingi-Pak’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 “Belport”
FDA records each applicant name separately; these may or may not be the same firm.