REAL INTELLIGENCE CORI— 510(k) K260601
Substantially EquivalentBlue Belt Technologies, Inc.
FDA 510(k) clearance K260601 for REAL INTELLIGENCE CORI, Substantially Equivalent on 2026-03-26. Applicant: Blue Belt Technologies, Inc.. Device class: 2.
Summary
Blue Belt Technologies' REAL INTELLIGENCE CORI is filed under OLO, orthopedic stereotaxic instruments. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Special 510(k), though the record lists Neurology as the classification panel.
Blue Belt Technologies filed from Pittsburgh, Pennsylvania. The decision came 30 calendar days after receipt (February 24 to March 26, 2026).
Clearance details
- Applicant
- Blue Belt Technologies, Inc.
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pittsburgh, PA, US
Recent devices under product code OLO
view allMore clearances from Blue Belt Technologies, Inc.
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.