FDA applicant
Sunfire Industries, Inc.
FDA records 1 decision for Sunfire Industries, Inc. (New Bern, NC) in 2016: 1 510(k) clearance. All are in product code LEJ (Booth, Sun Tan). 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 Sunfire Industries, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2016high 1 (2016) · low 0 (2017)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Sunfire 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