Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Blue Belt Technologies, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
151 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260601 | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | 2026-03-26 | 30 | 0 |
| K252841 | REAL INTELLIGENCE™ CORI™ XT (CORI XT) | Blue Belt Technologies, Inc. | 2025-12-05 | 88 | 0 |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2025-06-25 | 90 | 0 |
| K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | Blue Belt Technologies, Inc. | 2024-11-15 | 106 | 0 |
| K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | 2024-03-18 | 60 | 1 |
| K231963 | REAL INTELLIGENCE™ CORI™ | Blue Belt Technologies, Inc. | 2023-08-01 | 29 | 2 |
| K221224 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2022-08-19 | 113 | 0 |
| K220958 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022-07-27 | 117 | 0 |
| K220255 | REAL INTELLIGENCE CORI | Blue Belt Technologies, Inc. | 2022-03-29 | 57 | 0 |
| K212040 | RI.HIP MODELER | Blue Belt Technologies, Inc. | 2022-03-11 | 254 | 0 |
| K212537 | REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. | 2021-11-03 | 83 | 0 |
| K201022 | REAL INTELLIGENCE CORI (CORI) | Blue Belt Technologies, Inc. | 2020-06-12 | 53 | 0 |
| K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020-02-14 | 94 | 0 |
| K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019-06-28 | 52 | 0 |
| K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018-04-06 | 65 | 0 |
| K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017-05-02 | 85 | 0 |
| K160537 | Navio | Blue Belt Technologies, Inc. | 2016-05-19 | 83 | 0 |
| K152574 | Navio | Blue Belt Technologies, Inc. | 2015-10-20 | 41 | 0 |
| K143668 | Navio | Blue Belt Technologies, Inc. | 2015-03-20 | 86 | 0 |
| K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014-07-02 | 117 | 0 |
| K123380 | STRIDE UNICONDYLAR KNEE | Blue Belt Technologies, Inc. | 2013-05-31 | 211 | 2 |
| K121936 | NAVIOPFS | Blue Belt Technologies, Inc. | 2012-11-30 | 151 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda