Company · US
Blue Belt Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (2 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2026 | K260601 | REAL INTELLIGENCE CORI Blue Belt Technologies, Inc. | OLO |
| Dec 5, 2025 | K252841 | REAL INTELLIGENCE CORI XT (CORI XT) Blue Belt Technologies, Inc. | OLO |
| Jun 25, 2025 | K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services Blue Belt Technologies, Inc. | PBF |
| Nov 15, 2024 | K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services Blue Belt Technologies, Inc. | |
| Mar 18, 2024 | K240139 | Real Intelligence CORI Blue Belt Technologies, Inc. | OLO |
| Aug 1, 2023 | K231963 | REAL INTELLIGENCE CORI Blue Belt Technologies, Inc. | OLO |
| Aug 19, 2022 | K221224 | REAL INTELLIGENCE CORI Blue Belt Technologies, Inc. | OLO |
| Jul 27, 2022 | K220958 | Real Intelligence Cori Blue Belt Technologies, Inc. | OLO |
| Mar 29, 2022 | K220255 | REAL INTELLIGENCE CORI Blue Belt Technologies, Inc. | OLO |
| Mar 11, 2022 | K212040 | RI.HIP MODELER Blue Belt Technologies, Inc. | LLZ |
| Nov 3, 2021 | K212537 | REAL INTELLIGENCE CORI (CORI) Blue Belt Technologies, Inc. | OLO |
| Jun 12, 2020 | K201022 | REAL INTELLIGENCE CORI (CORI) Blue Belt Technologies, Inc. | OLO |
| Feb 14, 2020 | K193120 | Real Intelligence Cori Blue Belt Technologies, Inc. | OLO |
| Jun 28, 2019 | K191223 | NAVIO Blue Belt Technologies, Inc. | OLO |
| Apr 6, 2018 | K180271 | NAVIO Surgical System (NAVIO system) Blue Belt Technologies, Inc. | OLO |
| May 2, 2017 | K170360 | NAVIO Blue Belt Technologies, Inc. | OLO |
| May 19, 2016 | K160537 | Navio Blue Belt Technologies, Inc. | OLO |
| Oct 20, 2015 | K152574 | Navio Blue Belt Technologies, Inc. | OLO |
| Mar 20, 2015 | K143668 | Navio Blue Belt Technologies, Inc. | OLO |
| Jul 2, 2014 | K140596 | NAVIO Blue Belt Technologies, Inc. | OLO |
| May 31, 2013 | K123380 | STRIDE UNICONDYLAR KNEE Blue Belt Technologies, Inc. | HSX |
| Nov 30, 2012 | K121936 | NAVIOPFS Blue Belt Technologies, Inc. | OLO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2024 | Blue Belt Technologies, Inc CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anat Open, Classified |
OLO | K240139 |
| Jan 11, 2024 | Blue Belt Technologies, Inc CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S Open, Classified |
OLO | K231963 |
| Oct 5, 2023 | Blue Belt Technologies, Inc Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5)
Product Number: ROB10299 Open, Classified |
OLO | K231963 |