Data / Medical devices / United States / KL Distributing

KL Distributing: FDA-registered device maker in Hudson, FL, United States, 8 510(k) clearances

Name: KL Distributing FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

KL Distributing is registered with the FDA (registration 3004183512) in Hudson, FL, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 20, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004183512
Address: 7425 Sailfish Dr, Hudson, FL, United States, 34667
Owner or operator: KL DISTRIBUTING (9056236)
Roles: Manufacturer
First device listed: August 31, 2021
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	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
January 20, 2023	K222158	Capiflo 5001	JOW	Substantially Equivalent	K&L Distributing, Inc.	accessdata.fda.gov
June 21, 2019	K191151	JKH Stimulator Plus	NUH	Substantially Equivalent	Jkh USA, LLC	accessdata.fda.gov
February 21, 2019	K182578	Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
December 18, 2018	K182150	Devon 52 Sequential Compression Device	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
February 6, 2018	K173528	Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
February 1, 2018	K172828	Double Medical Cage System	MAX	Substantially Equivalent	Double Medical Technology, Inc.	accessdata.fda.gov
November 27, 2017	K172030	Devon 51	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov
July 11, 2017	K170814	Devon 24	JOW	Substantially Equivalent	Devon Medical Products (Jiangsu), Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 20, 2023. 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.