Data / Medical devices / United States / Klarity Medical Products, LLC

Klarity Medical Products, LLC: FDA-registered device maker in Heath, OH, United States, 7 510(k) clearances

Name: Klarity Medical Products, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Klarity Medical Products, LLC is registered with the FDA (registration 1530561) in Heath, OH, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 1, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1530561
FEI number: 3001236129
Address: 600 Industrial Pkwy, Heath, OH, United States, 43056
Owner or operator: KLARITY MEDICAL PRODUCTS, LLC (9031393)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 13, 2005
Registered through: 2026
Brand names listed: AccuCushion, KLARITY BASEPLATES, Klarity AccuCushion, Klarity Bolus, Klarity Moldable Cushion, Klarity Promise Baseplate, Klarity Prone Head Support, Klarity Carbon Fiber Head Support, and Klarity Lateral Head Support, Klarity SRS Baseplate and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Holder, Head, Radiographic	IWY	1	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Contract manufacturer, Manufacturer, Specification developer	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
November 1, 2022	K220539	Klarity SRS Baseplate, Klarity Promise Baseplate	IYE	Substantially Equivalent	Klarity Medical & Equipment (GZ) Co., Ltd.	accessdata.fda.gov
May 14, 2021	K202747	Klarity Bolus	IYE	Substantially Equivalent	Klarity Medical & Equipment (GZ) Co., Ltd.	accessdata.fda.gov
November 1, 2013	K132124	KLARITY VACUUM BAG, KLARITY MOLD CUSHION	IYE	Substantially Equivalent	Klarity Medical Products, LLC	accessdata.fda.gov
October 7, 2011	K112460	MULTIPLE	IYE	Substantially Equivalent	Larson Medical Products, Inc.	accessdata.fda.gov
February 4, 2011	K102753	TURBO TEMP 3	EBG	Substantially Equivalent	Danville Materials, Inc.	accessdata.fda.gov
November 12, 2002	K022708	KLARITY	IYE	Substantially Equivalent	Larson Products, Inc.	accessdata.fda.gov
August 31, 1978	K781151	REPROSIL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
July 31, 2020	86146	Class II	Terminated	Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients unde	Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.	accessdata.fda.gov

Compare with other makers

Updated November 1, 2022. 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.