Data / Medical devices / Mexico / Erika De Reynosa, S.A. De C.V.

Erika De Reynosa, S.A. De C.V.: FDA-registered device maker in CD, REYNOSA Tamaulipas, Mexico, 25 510(k) clearances

Name: Erika De Reynosa, S.A. De C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Erika De Reynosa, S.A. De C.V. is registered with the FDA (registration 8030665) in CD, REYNOSA Tamaulipas, Mexico. It lists 10 device types. The FDA files 25 510(k) clearances under its listings, the newest dated May 30, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030665
FEI number: 3002807744
Address: Mike Allen 1331 Parque Industrial Reynosa, CD, REYNOSA Tamaulipas, Mexico, 88780
Owner or operator: Fresenius Medical Care Renal Therapies Group, LLC (9030510)
Roles: Manufacturer
First device listed: January 8, 2008
Registered through: 2026
Brand names listed: 2008K@HOME HEMODIALYSIS MACHINE, 4 LEAD ECO PREFILLED W/SNAP DISCONNECT, 5008X CAREsystem, APD Luer Lock Adapter, CATHETER ADAPTER SEALING CAP, CombiSet - 2008 Series Home Hemodialysis with Prime Bag, CombiSet Hemodialysis Blood Tubing Set, CombiSet SMARTECH Hemodialysis Blood Tubing Sets and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Blood Circuit, Hemodialysis	KOC	2	Manufacturer	accessdata.fda.gov
Autonomous Extracorporeal Blood Leak Detector/Alarm	ODX	2	Manufacturer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer	accessdata.fda.gov
Disinfectant, Dialysate Delivery System	NII	2	Manufacturer	accessdata.fda.gov
Hemodialysis System For Home Use	ONW	2	Manufacturer	accessdata.fda.gov
Protector, Transducer, Dialysis	FIB	2	Manufacturer	accessdata.fda.gov
Set, Administration, For Peritoneal Dialysis, Disposable	KDJ	2	Manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Manufacturer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Manufacturer	accessdata.fda.gov
System, Peritoneal, Automatic Delivery	FKX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 30, 2025	K243505	5008X Hemodialysis System	KDI	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
April 3, 2025	K250404	staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch	KDJ	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
May 31, 2023	K213992	CombiSet Hemodialysis Blood Tubing Set	FJK	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
September 18, 2020	K201207	CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line	KOC	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
May 1, 2018	K173718	Liberty Cycler Set	FKX	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
February 14, 2018	K173651	Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set	KDJ	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
January 24, 2018	K173363	Cycler Drain Bag Set	KDJ	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
November 5, 2015	K152953	CRIT-LINE CLIP (CLIC) BLOOD CHAMBER	KOC	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
July 30, 2014	K141145	LIBERTY PDX CYCLER	FKX	Substantially Equivalent	Fresenius Medical Care Renal Therapies Group, LLC	accessdata.fda.gov
September 19, 2013	K124024	APD LUER-LOCK ADAPTER	KDJ	Substantially Equivalent	Fresensius Medical Care North America	accessdata.fda.gov
June 15, 2012	K120823	BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS	FJK	Substantially Equivalent	Fresenius Medical Care North America, Design Cente	accessdata.fda.gov
February 3, 2011	K070049	FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR	ONW	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
December 29, 2008	K083542	FRESENIUS STERILE STAY SAFE CAP	KDJ	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
March 31, 2005	K043363	FRESENIUS LIBERTY CYCLER	FKX	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
October 30, 2002	K022536	\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR	KOC	Substantially Equivalent	Fresenius Medical Care	accessdata.fda.gov
April 27, 2001	K010268	FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9	KOC	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
December 1, 2000	K003445	FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2	FIB	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
July 28, 2000	K001873	HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0	FJK	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
June 23, 2000	K001107	FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)	FJK	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
May 9, 2000	K000451	FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290	FJK	Substantially Equivalent	Fresenius Medical Care North America	accessdata.fda.gov
November 1, 1996	K962081	COMBILINES HEMODIALYSIS BLOOD TUBING SET	FJK	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.	accessdata.fda.gov
February 26, 1990	K896764	UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5	KDJ	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.	accessdata.fda.gov
October 13, 1982	K822550	SAFE LOCK TITANIUM ADAPTER SET	FKX	Substantially Equivalent	American Medical Products, Inc.	accessdata.fda.gov
October 13, 1982	K822546	SAFE LOCK SEALING CAPS	FKX	Substantially Equivalent	American Medical Products, Inc.	accessdata.fda.gov
August 31, 1981	K811986	THE AMP 80/2 PEDIATRIC CYCLER SYSTEM	FKX	Substantially Equivalent	American Medical Products, Inc.	accessdata.fda.gov

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Updated May 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.