Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000324175

FEI Number

1000324175

Entity Name

Halkey-Roberts Corporation

City/State/Country

Saint Petersburg, FL, US

Establishment Address

2700 Halkey-Roberts Place North, Saint Petersburg, FL 33716, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ATRION CORP. (Owner Number: 9914015)

Owner / Operator Contact Address

ONE ALLENTOWN PKWY., --, Allen, TX 75002, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Q2 VIAL ADAPTER Q-Flex, Q2 Robersite (Registered) Needlefree Injection Site Valve Lyka PORT Needle Free Access Device Q2 Stopcock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2006-01-20
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-11-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-05
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2008-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ATRION CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1649914	QUEST MEDICAL, INC.	ALLEN, TX, US
1043729	ATRION MEDICAL PRODUCTS, INC.	ARAB, AL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243985	Icu Medical, Inc.	Rio Drug Reconstitution Transfer Device	2025-01-22
K222718	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	Vial Adapter	2023-03-10
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2017	Baxter Corporation Englewood	2	0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.
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
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3042177665	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3012798826	BD SWITZERLAND SARL	Eysins Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000324175. Last updated year: 2026. Please use registration number 1000324175 when referencing this establishment in official correspondence.