FDA applicant
Blue Belt Technologies, Inc.
FDA records 22 decisions for Blue Belt Technologies, Inc. (Plymouth, MN) from 2012 to 2026: 22 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 20 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Blue Belt Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Blue Belt Technologies, 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) ReportOther applicant names beginning “Blue”
FDA records each applicant name separately; these may or may not be the same firm.