FDA applicant
Sable Industries, Inc.
FDA records 3 decisions for Sable Industries, Inc. (Oceanside, CA) from 1986 to 2009: 3 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and GES (Blade, Scalpel). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Sable Industries”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sable Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sable Industries, 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