Data / Medical devices / United States / Blue Belt Technologies, Inc.

Blue Belt Technologies, Inc.: FDA-registered device maker in Pittsburgh, PA, United States, 18 510(k) clearances

Name: Blue Belt Technologies, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Blue Belt Technologies, Inc. is registered with the FDA (registration 3016090213) in Pittsburgh, PA, United States. It lists 11 device types. The FDA files 18 510(k) clearances under its listings, the newest dated March 26, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Blue Belt Technologies, Inc.

FDA registration number: 3016090213
Address: 2875 Railroad Street, Pittsburgh, PA, United States, 15222
Owner or operator: Smith & Nephew, Inc. (1020279)
Roles: Manufacturer
First device listed: October 7, 2016
Registered through: 2027
Brand names listed: Brainlab Knee, CORI, CORIOGRAPH Pre-Op Planning and Modeling Services, HIP7, NAVIO, REAL INTELLIGENCE CORI, REAL INTELLIGENCE CORI (CORI), REAL INTELLIGENCE CORI XT and more

Devices it lists

Device	Product code	Class	Role	Source
Orthopaedic Surgical Planning And Instrument Guides	PBF	2	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer	NJD	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 26, 2026	K260601	REAL INTELLIGENCE CORI	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
December 5, 2025	K252841	REAL INTELLIGENCE CORI XT (CORI XT)	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
June 25, 2025	K250921	CORIOGRAPH Pre-Op Planning and Modeling Services	PBF	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
November 15, 2024	K242272	CORIOGRAPH Pre-Op Planning and Modeling Services		Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
March 18, 2024	K240139	Real Intelligence CORI	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
August 19, 2022	K221224	REAL INTELLIGENCE CORI	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
March 29, 2022	K220255	REAL INTELLIGENCE CORI	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
March 11, 2022	K212040	RI.HIP MODELER	LLZ	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
November 3, 2021	K212537	REAL INTELLIGENCE CORI (CORI)	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
June 12, 2020	K201022	REAL INTELLIGENCE CORI (CORI)	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
June 2, 2020	K193307	HIP7	OLO	Substantially Equivalent	Brainlab AG	accessdata.fda.gov
February 14, 2020	K193120	Real Intelligence Cori	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
June 28, 2019	K191223	NAVIO	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
May 2, 2017	K170360	NAVIO	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
May 19, 2016	K160537	Navio	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
October 20, 2015	K152574	Navio	OLO	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
May 31, 2013	K123380	STRIDE UNICONDYLAR KNEE	HSX	Substantially Equivalent	Blue Belt Technologies, Inc.	accessdata.fda.gov
April 4, 2011	K102990	BRAINLAB KNEE	OLO	Substantially Equivalent	Brainlab AG	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 7, 2024	94635	Class II	Ongoing	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 anatomical structures du	CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay	accessdata.fda.gov
November 13, 2023	93620	Class II	Ongoing	CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013S	Possibility that the user is unable to resolve drill disconnection error messages.	accessdata.fda.gov
September 7, 2023	93046	Class II	Ongoing	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299	CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis	accessdata.fda.gov

Compare with other makers

Updated March 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.