Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2321034

FEI Number

3003399884

Entity Name

INNOVATE MEDICAL, LLC

City/State/Country

Johnson City, TN, US

Establishment Address

2210 Buffalo Road, Johnson City, TN 37604, US

Establishment Type(s)

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

Owner / Operator

Innovate Medical, LLC (Owner Number: 10028796)

Owner / Operator Contact Address

2210 Buffalo Road, Johnson City, TN 37604, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INNOVATE MEDICAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	Class 2	870.2750	2016-02-14
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2024-02-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-07-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-07-05
OIP	Radiology-Diagnostic Kit	Radiology	Class 2	892.1680	2023-01-27
PMQ	Peripheral Blood Processing Device For Wound Management	Hematology	Class 2	864.9245	2022-11-29
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2009-03-06
QLW	Covid-19 Test Home Collection Kit Devices	Unknown	Class N	N/A	2021-12-29
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2009-03-06

Official Correspondent

Susan Johnston

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Innovate Medical, 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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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3035642068	Honduras Kitting, S.A.	Villanueva Cortes, HN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2321034. Last updated year: 2026. Please use registration number 2321034 when referencing this establishment in official correspondence.