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Haemonetics Corporation: FDA-registered device maker in Boston, MA, United States, 19 510(k) clearances

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

Haemonetics Corporation is registered with the FDA (registration 1219343) in Boston, MA, United States. It lists 15 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 30, 2025. 17 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1219343
Address: 125 Summer Street, Boston, MA, United States, 02110
Owner or operator: Haemonetics Corporation (1219343)
Roles: Manufacturer, Specification developer
First device listed: December 11, 2007
Registered through: 2026
Brand names listed: ACP215, Antiplatelet Reagent, BloodTrack, BloodTrack 4.7, Cell Saver 5, Cell Saver 5, Cell Saver 5+, Cell Saver Elite, Cell Saver Elite+ and more

Devices it lists

Device	Product code	Class	Role	Source
Activated Whole Blood Clotting Time	JBP	2	Specification developer	accessdata.fda.gov
Apparatus, Autotransfusion	CAC	2	Specification developer	accessdata.fda.gov
Blood Establishment Computer Software And Accessories	MMH	2	Manufacturer	accessdata.fda.gov
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2	Specification developer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Specification developer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Specification developer	accessdata.fda.gov
Pump, Infusion	FRN	2	Specification developer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Specification developer	accessdata.fda.gov
Separator, Automated, Blood Cell And Plasma, Therapeutic	LKN	U	Specification developer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Specification developer	accessdata.fda.gov
System, Automated Platelet Aggregation	JOZ	2	Specification developer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Specification developer	accessdata.fda.gov
System, Multipurpose For In Vitro Coagulation Studies	JPA	2	Specification developer	accessdata.fda.gov
System, Processing For Frozen Blood	KSW	2	Specification developer	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
April 30, 2025	K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	Substantially Equivalent	Haemonetics	accessdata.fda.gov
January 15, 2025	K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
March 29, 2024	K232018	Citrated: K, KH, RTH, FFH	JPA	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
November 15, 2022	K221722	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)	CAC	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
May 9, 2019	K183160	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	JPA	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
January 3, 2017	K162423	Haemonetics Cell Saver Elite/Elite+ Autotransfusion System	CAC	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
June 26, 2015	K150041	CORA (Coagulation Resonance Analysis) System	JPA	Substantially Equivalent	Coramed Technologies, LLC	accessdata.fda.gov
January 3, 2015	K140893	CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY	JOZ	Substantially Equivalent	Coramed Technologies, LLC	accessdata.fda.gov
May 22, 2012	K120586	CELL SAVER ELITE	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
December 3, 2010	K101907	HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
January 31, 2007	K062604	RAPIDTEG TEG-ACT TEST	JBP	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
October 5, 2005	K052626	SMARTSUCTION HARMONY DEVICE	BTA	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
September 1, 2004	K041502	THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY	JOZ	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
January 8, 2002	K014083	HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
September 14, 2000	K002177	THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES	JPA	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
May 5, 2000	K993678	THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES	JPA	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
June 4, 1996	K953681	HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET	LKN	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
January 5, 1994	K932890	CELL SAVER 5 SYSTEM	CAC	Substantially Equivalent	Haemonetics Corp.	accessdata.fda.gov
December 9, 1985	K852645	FLUID MANAGEMENT SYSTEM	FRN	Substantially Equivalent	Haemonetics Corp.	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 26, 2022	90323	Class II	Terminated	TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034	Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.	accessdata.fda.gov
April 19, 2022	90358	Class II	Terminated	Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016).	When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.	accessdata.fda.gov
February 19, 2020	85120	Class II	Terminated	TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies	Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice vers	accessdata.fda.gov
October 21, 2019	84183	Class II	Terminated	CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as	Potential to develop leaks at the inner core of Cell Saver 5/5+ and Cell Saver Elite/Elite +125ml and 225ml bowl sets. Which could result in fluid being trapped inside the bowl core, causing a long empty device error message with the possibility of incomplete washing.	accessdata.fda.gov
July 13, 2018	80740	Class II	Terminated	Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during su	OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.	accessdata.fda.gov
August 2, 2017	79031	Class II	Terminated	Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of b	Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing.	accessdata.fda.gov
January 26, 2015	70352	Class II	Terminated	Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.	Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.	accessdata.fda.gov
June 20, 2013	65635	Class II	Terminated	TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies	Research Use Only (RUO) parameters were included in TEG 5000 User Manual.	accessdata.fda.gov
July 27, 2011	59379	Not yet classified	Terminated	Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics Cardiovascular Periope	Updated Operations Manual for the deployment of the spill collection system and cleaning	accessdata.fda.gov
April 29, 2011	58658	Not yet classified	Terminated	Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only: 1050-110-ENG Outside US: 1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER, 1050-240-DUT, 1050-240-	2 Models Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled Model 2: OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum	accessdata.fda.gov
January 31, 2011	57855	Not yet classified	Terminated	2380 MINI Hand-Held Tube Sealer Power Source (including a 23802000 Battery Pack) The Model 2380 Power Source is an instrument that generates RF power for making seals on tubing made of RF reactive thermoplastic materials	Battery pack may have exposed wire becoming hot	accessdata.fda.gov
January 25, 2011	57805	Not yet classified	Terminated	Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US	Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.	accessdata.fda.gov
October 15, 2007	45427	Not yet classified	Terminated	Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)	Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest	accessdata.fda.gov
July 28, 2006	36005	Not yet classified	Terminated	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US	Faulty circuit board may short circuit and cause electric shock to operator	accessdata.fda.gov
December 21, 2005	34372	Not yet classified	Terminated	Haemonetics Cell Saver 5 Autogolous Blood Recovery System Model Numbr: LN02005-110-E	Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard	accessdata.fda.gov
July 22, 2005	32844	Not yet classified	Terminated	cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperativ	Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System	accessdata.fda.gov
December 17, 2002	25342	Not yet classified	Terminated	Haemonetics Cell Saver 5 Fast Pack List Number: 260	Disposable Set for Autologous Blood recovery may leak saline at the Y-connector	accessdata.fda.gov

Compare with other makers

Updated April 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.