FDA applicant
Blue Sky Bio, LLC
FDA records 21 decisions for Blue Sky Bio, LLC (Grayslake, IL) from 2000 to 2024: 21 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NXC (Aligner, Sequential). Since 2016 its 510(k)s took a median of 190 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Blue Sky Bio”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Blue Sky Bio, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Blue Sky Bio, LLC’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 “Blue”
FDA records each applicant name separately; these may or may not be the same firm.