Data / Medical devices / United States / Terumo BCT, Inc..

Terumo BCT, Inc..: FDA-registered device maker in Lakewood, CO, United States, 15 510(k) clearances

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

Terumo BCT, Inc.. is registered with the FDA (registration 1722028) in Lakewood, CO, United States. It lists 12 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 5, 2019. 10 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Terumo BCT, Inc..

FDA registration number: 1722028
FEI number: 1000117351
Address: 10811 W Collins Ave, Lakewood, CO, United States, 80215
Owner or operator: Terumo BCT, INC. (9002708)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: November 30, 1993
Registered through: 2027
Brand names listed: Anticoagulant Connection Adapter, Anticoagulant free flow restriction, Atreus 2 Component Processing Set without RBC filter or solutions, Atreus 2C, Dry Set, ASM 2.1, Atreus Whole Blood Process System, Blood Cell Processor (Model 2 - IBM 2991), COBE 2991 Cell Processor, COBE Spectra Apheresis System & Trima Automated Blood Component Collection System/7 Day Platelet and more

Devices it lists

Device	Product code	Class	Role	Source
Blood Establishment Computer Software And Accessories	MMH	2	Manufacturer	accessdata.fda.gov
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Device, Heat-Sealing	KSD	1	Manufacturer	accessdata.fda.gov
Device, Warming. Blood And Plasma	KZL	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell And Plasma, Therapeutic	LKN	U	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Manufacturer, Specification developer	accessdata.fda.gov
Separator, Semi-Automated, Blood Component	MYY	1	Manufacturer	accessdata.fda.gov
Set, Transfer (Blood/Plasma)	KSB	2	Manufacturer, Specification developer	accessdata.fda.gov
Supplies, Blood-Bank	KSS	1	Manufacturer	accessdata.fda.gov
System, Processing For Frozen Blood	KSW	2	Manufacturer	accessdata.fda.gov
Tourniquet, Pneumatic	KCY	1	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
February 5, 2019	K183081	Spectra Optia Apheresis System	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
November 1, 2018	K181049	Spectra Optia Apheresis System	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
March 2, 2018	K172590	Spectra Optia Apheresis System	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
February 16, 2017	K162365	T-Cuff	KCY	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
January 14, 2016	K153601	Spectra Optia Apheresis System	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
September 11, 2015	K151368	Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter	LKN	Substantially Equivalent	Terumo Bct	accessdata.fda.gov
March 23, 2015	K141938	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
December 6, 2013	K132429	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
August 8, 2013	K131744	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE	LKN	Substantially Equivalent	Terumobct, Inc.	accessdata.fda.gov
January 20, 2012	K113480	SPECTRA OPTIA APHERESIS SYSTEM	LKN	Substantially Equivalent	Caridianbct, Inc..	accessdata.fda.gov
November 19, 2010	K103090	SPECTRA OPTIA R APHERESIS SYSTEM	LKN	Substantially Equivalent	Caridianbct, Inc..	accessdata.fda.gov
August 2, 2007	K071079	SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200	LKN	Substantially Equivalent	Gambro Bct, Inc.	accessdata.fda.gov
October 18, 1989	K893962	COBE 2991 SUPPLEMENTARY DISPOSABLE SETS	LKN	Substantially Equivalent	Cobe Laboratories, Inc.	accessdata.fda.gov
September 12, 1983	K831004	AUTOMATED 8400 BLOOD CELL SEPARATOR	LKN	Substantially Equivalent	Intl. Business Machines	accessdata.fda.gov
January 10, 1977	K760856	BLOOD CELL PROCESSOR MODEL 2 IBM 2991	GKT	Substantially Equivalent	Intl. Business Machines	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
October 20, 2017	78309	Class II	Terminated	HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for	Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.	accessdata.fda.gov
October 20, 2017	78307	Class II	Terminated	HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO	The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The expiration noted was not beyond initiation date of the recall. Since the product is noted as sterile, the clearance for K1033	accessdata.fda.gov
November 3, 2016	75589	Class II	Terminated	Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.	Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.	accessdata.fda.gov
September 11, 2013	66268	Class II	Terminated	Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated	Potential for leur connector to leak or have cracks.	accessdata.fda.gov
May 4, 2012	57371	Not yet classified	Terminated	Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Ex	Defective product may result in decreased efficacy.	accessdata.fda.gov
October 26, 2011	53828	Not yet classified	Terminated	Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.	Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.	accessdata.fda.gov
September 21, 2011	60174	Not yet classified	Terminated	Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.	Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.	accessdata.fda.gov
December 9, 2010	58909	Not yet classified	Terminated	Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be u	An additional air detection system is being added to all existing systems to detect air in the system's return line.	accessdata.fda.gov
June 1, 2010	53196	Not yet classified	Terminated	Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.	Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.	accessdata.fda.gov
September 18, 2007	44915	Not yet classified	Terminated	Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.	Under specific conditions, apheresis machine could return up to 60mL of air to the patient.	accessdata.fda.gov

Compare with other makers

Updated February 5, 2019. 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.