Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010824458

FEI Number

3010824458

Entity Name

FABRITEQ

City/State/Country

Knoxville, TN, US

Establishment Address

11220 Gilbert Dr, Knoxville, TN 37932, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

FabriTEQ (Owner Number: 10046621)

Owner / Operator Contact Address

11220 Gilbert Dr, Knoxville, TN 37932, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpO2 Sensor Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-09-10
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-02-25
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-04-21
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2019-12-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2016-02-25
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-01-11
PNU	Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery	Obstetrics/Gynecology	Class 2	884.5210	2023-05-22

Official Correspondent

David Dewitt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FabriTEQ

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
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22

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
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.

Similar Registrations

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3042617688	LMC OPCO, LLC	Woodstock, GA, US
3004189237	ADVANCED BIOTECH PRODUCTS (P), LTD.	CHENNAI Tamil Nadu, IN
3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010824458. Last updated year: 2026. Please use registration number 3010824458 when referencing this establishment in official correspondence.