Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026544741

FEI Number

3026544741

Entity Name

KX MEDICAL, INC.

City/State/Country

Gallatin, TN, US

Establishment Address

110 Caroline Way, Gallatin, TN 37066, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KX Medical, Inc. (Owner Number: 10087425)

Owner / Operator Contact Address

110 Caroline Way, Gallatin, TN 37066, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160783

PMA Number

N/A

All Registered Proprietary Names

Procellera Composite Antibacterial Wound Dressing SomniFix Sleep Therapy Procellera Antimicrobial Wound Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-02-26
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2023-03-08
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-02-25

Official Correspondent

Frederick Knox III

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KX Medical, Inc.

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

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3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026544741. Last updated year: 2026. Please use registration number 3026544741 when referencing this establishment in official correspondence.