Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1530561

FEI Number

3001236129

Entity Name

KLARITY MEDICAL PRODUCTS, LLC

City/State/Country

Heath, OH, US

Establishment Address

600 Industrial Pkwy, Heath, OH 43056, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

KLARITY MEDICAL PRODUCTS, LLC (Owner Number: 9031393)

Owner / Operator Contact Address

600 Industrial Pkwy, --, Heath, OH 43056, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112460

PMA Number

N/A

All Registered Proprietary Names

Klarity White, Contour Blend, Contour Pro, Klarity Easy Fit, Klarity Solo Klarity Bolus TrueForm Cushion Klarity AccuCushion Klarity Vacuum Bag Klarity Moldable Cushion AccuCushion Klarity Prone Head Support, Klarity Carbon Fiber Head Support, and Klarity Lateral Head Support MEDIBORD Leg Positioner SBRT System KLARITY BASEPLATES OPTEK BASEPLATES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2006-10-05
ELW	Material, Impression	Dental	Class 2	872.3660	2019-03-14
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-06-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-11-14
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2006-10-05
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2018-01-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2011-12-21

Official Correspondent

Michelle Fritch

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KLARITY MEDICAL PRODUCTS, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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3023344913	AR ORTHOPEDICS, LLC	Newberry, FL, US
3041725026	Fill Mill	Lakewood, NJ, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1530561. Last updated year: 2026. Please use registration number 1530561 when referencing this establishment in official correspondence.