Data / Medical devices / United States / Medivators Inc

Medivators Inc: FDA-registered device maker in Minneapolis, MN, United States, 16 510(k) clearances

Name: Medivators Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medivators Inc is registered with the FDA (registration 2150060) in Minneapolis, MN, United States. It lists 12 device types. The FDA files 16 510(k) clearances under its listings, the newest dated October 2, 2026. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2150060
Address: 14605 28th Avenue North, Minneapolis, MN, United States, 55447
Owner or operator: STERIS Corporation (2150060)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed: January 25, 2008
Registered through: 2027
Brand names listed: Adaspor Plus Minimum Required Concentration (MRC) Test Strips (78401114), Advantage Plus Endoscope Reprocessing System, Advantage Plus Pass-Thru Automated Endoscope Reprocessor, CER Series Automatic Endoscope Reprocessor (CFE), Connectors for MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (PY-SD, HP-MF), DOUBLE BALLOON PULL THRU SINGLE, DOUBLE BALLOON PULL THRU W/ STUBBY COMBO, DOUBLE ENDED STUBBY BRUSH (180) and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Accessories, Cleaning, For Endoscope	FEB	2	Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Complaint file establishment	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Contract manufacturer	accessdata.fda.gov
Disinfectant, Subsystem, Water Purification	NIH	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Endoscope Maintenance System	PUP	2	Specification developer	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Manufacturer for export, Specification developer	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Manufacturer	accessdata.fda.gov
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	MSY	2	Manufacturer for export	accessdata.fda.gov
System, Dialysate Delivery, Single Patient	FKP	2	Manufacturer for export	accessdata.fda.gov
Washer, Cleaner, Automated, Endoscope	NVE	2	Complaint file establishment, 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
October 2, 2026	K261791	MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor	FEB	Substantially Equivalent	Steris	accessdata.fda.gov
May 2, 2025	K251048	Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118	JOJ	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
January 14, 2022	K213833	SCOPE BUDDY PLUS Endoscope Flushing Aid	FEB	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
December 19, 2017	K172677	Advantage Plus Pass-Thru	FEB	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
December 21, 2016	K162128	Scope Buddy Plus Endoscope Flushing Aid	FEB	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
March 11, 2016	K152394	Rapicide PA High-Level Disinfectant Test Strips	JOJ	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
August 27, 2014	K133724	MINNCARE HD	NIH	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
October 12, 2012	K120652	RAPICIDE OPA-28 TEST STRIP	JOJ	Substantially Equivalent	Serim Research Corp.	accessdata.fda.gov
September 27, 2012	K120306	RAPICIDE OPA-28	MED	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
January 13, 2011	K102996	MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR	FEB	Substantially Equivalent	Medivators Reprocessing Systems	accessdata.fda.gov
April 5, 2010	K092387	MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM	FEB	Substantially Equivalent	Minntech Corp.	accessdata.fda.gov
February 13, 2009	K082988	MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANT	FEB	Substantially Equivalent	Medivators Reprocessing Systems	accessdata.fda.gov
May 12, 2008	K080750	BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR	JOJ	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
August 17, 2000	K993042	MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT	MED	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
February 22, 1994	K914145	DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES	FEB	Substantially Equivalent	Medivators, Inc.	accessdata.fda.gov
January 14, 1988	K871712	MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.	NVE	Substantially Equivalent	Machida America, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 20, 2021	87894	Class II	Terminated	Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.	The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.	accessdata.fda.gov
October 9, 2019	84109	Class II	Terminated	Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intende	Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.	accessdata.fda.gov
August 3, 2015	72122	Class II	Terminated	Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardio	Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification.	accessdata.fda.gov
June 15, 2010	56189	Not yet classified	Terminated	DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.	The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the pati	accessdata.fda.gov

Compare with other makers

Updated October 2, 2026. 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.