Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1035907

FEI Number

1035907

Entity Name

EXELINT INTERNATIONAL, CO.

City/State/Country

Redondo Beach, CA, US

Establishment Address

2500 Santa Fe Avenue, Redondo Beach, CA 90278, US

Establishment Type(s)

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

Owner / Operator

EXELINT INTERNATIONAL, CO. (Owner Number: 10024414)

Owner / Operator Contact Address

2500 Santa Fe Ave, Redondo Beach, CA 90278, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052103

PMA Number

N/A

All Registered Proprietary Names

EXEL Multi Sample Blood Collecting Needle Multiject Multi-Sample Luer Adapter EXEL Luer Lock Holder with Pre-Attached Multi-Sample Sample Adapter EXEL Injection Plug with Cap EXEL Huber Needle EXEL I.V. Extension Set Exel Zorband Pressure Bandage EXEL Multi-Sample Luer Holder EXEL Catheter Tip Syringe EXEL Curved Tip Syringe EXEL Disposable Syringe with SecureTouch Safety Needle EXEL Disposable Syringe with Needle EXEL Hypodermic Needle EXEL Disposable Syringe EXEL 1ml Delivery Syringe EXEL Surgical Blade EXEL Disposable Syringe Comfortpoint Insulin Syringe EXEL Hypodermic Needle EXEL Disposable Syringe with Needle EXEL HUBER INFUSION SET WITHOUT (Y) INJECTION SITE SecureTouch+ Safety Huber Infusion Set SecureTouch Safety Scalp Vein Set EXEL Disposable Scalpel EXEL Aluminum Hub Blunt Needle EXEL I.V. Administration Set EXEL Disposable Syringe with SecureTouch Safety Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-11-06
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2017-11-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-06-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-06
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-09-26
IQG	Adaptor, Holder, Syringe	Physical Medicine	Class 1	890.5050	2024-11-18
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-05-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-01-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-01-09
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2026-01-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-06
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2024-11-07
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-07-02
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-11-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-06
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-11-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-03-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-07-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-02-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-02-06
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2024-07-02
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2019-07-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-11-06
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2017-11-08

Official Correspondent

Stefanie Ng

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EXELINT INTERNATIONAL, CO.

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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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

Similar Registrations

Registration Number	Establishment Name	Location
3027338968	RONCADELLE OPERATIONS SRL	Castel Mella Brescia, IT
3000214934	ALMAC PHARMA SERVICES LLC	Audubon, PA, US
3006850123	JAPAN IRRADIATION SERVICE CO., LTD	Naka-gun Ibaraki, JP
3029328631	PEGASUS IMPORTS	Houston, TX, US
3010621964	ATLAS MEDICAL PRODUCTS LLC	Hialeah, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1035907. Last updated year: 2026. Please use registration number 1035907 when referencing this establishment in official correspondence.