Blue Belt Technologies, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Blue Belt Technologies, Inc.” (first 2012, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 84 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 151 |
| 2013 | 1 | 211 |
| 2014 | 1 | 117 |
| 2015 | 2 | 64 |
| 2016 | 1 | 83 |
| 2017 | 1 | 85 |
| 2018 | 1 | 65 |
| 2019 | 1 | 52 |
| 2020 | 2 | 74 |
| 2021 | 1 | 83 |
| 2022 | 4 | 115 |
| 2023 | 1 | 29 |
| 2024 | 2 | 83 |
| 2025 | 2 | 89 |
| 2026 | 1 | 30 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Blue Belt Technologies, Inc. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 18 | 18 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (20)
- Radiology (1)
Most recent Blue Belt Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260601 | REAL INTELLIGENCE CORI | OLO | 2026-03-26 | 30 |
| K252841 | REAL INTELLIGENCE CORI XT (CORI XT) | OLO | 2025-12-05 | 88 |
| K250921 | CORIOGRAPH Pre-Op Planning and Modeling Services | PBF | 2025-06-25 | 90 |
| K242272 | CORIOGRAPH Pre-Op Planning and Modeling Services | — | 2024-11-15 | 106 |
| K240139 | Real Intelligence CORI | OLO | 2024-03-18 | 60 |
| K231963 | REAL INTELLIGENCE CORI | OLO | 2023-08-01 | 29 |
| K221224 | REAL INTELLIGENCE CORI | OLO | 2022-08-19 | 113 |
| K220958 | Real Intelligence Cori | OLO | 2022-07-27 | 117 |
| K220255 | REAL INTELLIGENCE CORI | OLO | 2022-03-29 | 57 |
| K212040 | RI.HIP MODELER | LLZ | 2022-03-11 | 254 |
12 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2024-05-07.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Blue Sky Bio, LLC (21 510(k)s)
- Blue Ridge Media Co. (11 510(k)s)
- Blue Ortho (9 510(k)s)
- Blue Sky Medical Group Incorporated (4 510(k)s)
- Blue Planet Industries, Inc. (3 510(k)s)
- Blue Sail Medical Co.,Ltd (2 510(k)s)
- Blue Spark Technologies, Inc. (2 510(k)s)
- Blue Torch Medical Technologies (2 510(k)s)
- Blue X Imaging Srl (2 510(k)s)
- Blue Cross Bio-Medical Co., Ltd. (1 510(k)s)
- Blue Dent Dental (1 510(k)s)
- Blue Egg CO (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Blue Belt Technologies, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Blue Belt Technologies, Inc.” (first 2012, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Blue Belt Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blue Belt Technologies, Inc. is 86 days. Since 2017: 84 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Blue Belt Technologies, Inc.?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 18); HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, 1); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 22 Blue Belt Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLO, Blue Belt Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.