# Blue Belt Technologies, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 22 (2012–2026): 22 510(k) clearances
- Product codes: OLO (18), LLZ (1), PBF (1), HSX (1)
- 510(k) review time since 2016: median 83 days, against 91 for FDA's reviews in the same codes and years (12 of 16 faster)
- Predicates its devices cite: 30 (20 its own); citations of its devices by later devices: 26 (20 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mako Surgical Corp.: 3 (https://510kreport.com/company/mako-surgical)
- Blue Ortho: 1 (https://510kreport.com/company/blue-ortho)
- Orthosoft, Inc.: 1 (https://510kreport.com/company/orthosoft)
- Onefit Medical: 1 (https://510kreport.com/company/onefit-medical)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Materialise NV: 1 (https://510kreport.com/company/materialise)
- Corin, Ltd.: 1 (https://510kreport.com/company/corin)
- Zimmer, Inc.: 1 (https://510kreport.com/company/zimmer)

## Firms that cite its devices most
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)
- Consensus Orthopedics, Inc.: 1 (https://510kreport.com/company/consensus-orthopedics)
- Navbit Pty, Ltd.: 1 (https://510kreport.com/company/navbit)
- Enztec Limited: 1 (https://510kreport.com/company/enztec)
- Bodycad Laboratories, Inc.: 1 (https://510kreport.com/company/bodycad-laboratories)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K240139: Real Intelligence™ CORI™ (2024), cited by 3
- K221224: Real Intelligence Cori (2022), cited by 3
- K191223: NAVIO (2019), cited by 2
- K220255: Real Intelligence Cori (2022), cited by 2
- K212040: RI.Hip Modeler (2022), cited by 2
- K123380: Stride Unicondylar Knee (2013), cited by 2

## Recent decisions
- K260601: Real Intelligence™ Cori™ (Mar 26, 2026)
- K252841: Real Intelligence™ Cori™ XT (Cori XT) (Dec 5, 2025)
- K250921: CORIOGRAPH Pre-Op Planning and Modeling Services (Jun 25, 2025)
- K242272: CORIOGRAPH Pre-Op Planning and Modeling Services (Nov 15, 2024)
- K240139: Real Intelligence™ CORI™ (Mar 18, 2024)
- K231963: Real Intelligence™ Cori™ (Aug 1, 2023)
- K221224: Real Intelligence Cori (Aug 19, 2022)
- K220958: Real Intelligence Cori (Jul 27, 2022)

Source page: https://510kreport.com/company/blue-belt-technologies