Company ยท US
Haemonetics Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2025. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (0 in 12 months)
46recalls (0 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAC | Apparatus, Autotransfusion | 57 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 10 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 3 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 3 |
| FPA | Set, Administration, Intravascular | 2 |
| FRN | Pump, Infusion | 2 |
| CAK | Microfilter, Blood Transfusion | 1 |
| CAL | Laryngoscope, Non-Rigid | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 |
| KSD | Device, Heat-Sealing | 1 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 30, 2025 | K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge Haemonetics | JPA |
| Jan 15, 2025 | K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge Haemonetics Corporation | JPA |
| Mar 29, 2024 | K232018 | Citrated: K, KH, RTH, FFH Haemonetics Corporation | JPA |
| Nov 15, 2022 | K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) Haemonetics Corporation | CAC |
| May 9, 2019 | K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge Haemonetics Corporation | JPA |
| Apr 19, 2017 | K160502 | TEG 6s Hemostasis System Haemonetics Corporation | JPA |
| Jan 3, 2017 | K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System Haemonetics Corporation | CAC |
| May 24, 2016 | K160197 | Haemonetics Cell Saver Elite Autotransfusion System Haemonetics Corporation | CAC |
| Oct 25, 2012 | K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM Haemonetics Corp. | CAC |
| May 22, 2012 | K120586 | CELL SAVER ELITE Haemonetics Corp. | CAC |
| Dec 3, 2010 | K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM Haemonetics Corp. | CAC |
| Oct 4, 2006 | K062801 | SMARTSUCTION SOLO DEVICE Haemonetics Corp. | BTA |
| May 17, 2006 | K061103 | HAEMONETICS 40U RBC FILTER BAG Haemonetics Corp. | CAK |
| Nov 21, 2005 | K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) Haemonetics Corp. | CAC |
| Oct 5, 2005 | K052626 | SMARTSUCTION HARMONY DEVICE Haemonetics Corp. | BTA |
| Jan 4, 2005 | K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM Haemonetics Corp. | CAC |
| Jan 8, 2002 | K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM Haemonetics Corp. | CAC |
| Nov 18, 1999 | K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER Haemonetics Corp. | CAC |
| Jun 4, 1996 | K953681 | HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET Haemonetics Corp. | LKN |
| Jul 20, 1995 | K944232 | AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS Haemonetics Corp. | CAC |
| Jan 5, 1994 | K932890 | CELL SAVER 5 SYSTEM Haemonetics Corp. | CAC |
| Nov 13, 1990 | K904474 | HAEMONETICS LN 200F COLLECTION RESERVOIR Haemonetics Corp. | CAC |
| Nov 13, 1990 | K904041 | HAEMONETICS CELL SAVER 4 PLUS Haemonetics Corp. | CAC |
| Oct 19, 1989 | K893394 | ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR Haemonetics Corp. | CAC |
| Dec 27, 1988 | K883934 | CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM Haemonetics Corp. | CAC |
| Jan 11, 1988 | K872895 | HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. Haemonetics Corp. | CAL |
| May 6, 1986 | K860969 | FLUID MANAGEMENT SYSTEM (MODIFIED) Haemonetics Corp. | FRN |
| Dec 9, 1985 | K852645 | FLUID MANAGEMENT SYSTEM Haemonetics Corp. | FRN |
| Sep 3, 1985 | K852425 | CELL SAVER SUCTION SYSTEM Haemonetics Corp. | CAC |
| Jul 1, 1981 | K811449 | HAEMONETICS 1000ML COMPONENT BAG Haemonetics Corp. | KSR |
| May 8, 1981 | K810711 | HAEMONETICS 600 ML. COMPONENT BAG Haemonetics Corp. | KSR |
| Mar 31, 1981 | K810365 | HAEMONETICS 170 Y INFUSION SET Haemonetics Corp. | FPA |
| Mar 31, 1981 | K810313 | HAEMONETICS 1400 ML THERAPEUTIC BAG Haemonetics Corp. | KSR |
| Mar 5, 1981 | K810076 | PHERESIS NEEDLE ASSEMBLY Haemonetics Corp. | GAA |
| Jan 8, 1981 | K802674 | RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS. Haemonetics Corp. | CAC |
| Apr 16, 1980 | K800358 | Y-TYPE INFUSION SET (2 LEAD) Haemonetics Corp. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2022 | Haemonetics Corporation TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 Terminated |
JPA | K002177 |
| Apr 19, 2022 | Haemonetics Corporation 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),
Platelet Terminated |
JPA | K002177 K041502 |
| Feb 19, 2020 | Haemonetics Corporation 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 Terminated |
JPA | K002177 |
| Oct 21, 2019 | Haemonetics Corporation Japan DISP SET, 263J, 205J, HAR - 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 a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation Japan DISP SET, 263J, 205J, 208 - 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 a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processin Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processin Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing th Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, pr Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN DISP SET, 261J, 205J, HAR - 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 a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN DISP SET, 261J, 205J, 208 - 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 a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN BASIC HI SPEED CS5 SET,LN 263J - 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 Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN LOW VOL(125ML) CS5 SET,LN 261J - 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 Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 125 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 t Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a resu Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a resul Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation Cell Saver5/5+ Bowl Kit (225 ml) 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 Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 225 mL, 20 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 Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 125 mL, 20 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 a Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 125 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 Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent t Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Bowl Kit-125 mL 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 operati Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation 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 Terminated |
CAC | K932890 |
| Jul 13, 2018 | Haemonetics Corporation Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs.
Product Code: OPT-R-1000
The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intra Terminated |
CAC | K122262 |
| Jul 13, 2018 | Haemonetics Corporation 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 pos Terminated |
CAC | K992723 |
| Aug 2, 2017 | Haemonetics Corporation Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70
Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery Terminated |
CAC | K101907 |
| Aug 2, 2017 | Haemonetics Corporation 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 recover Terminated |
CAC | K014083 |
| Feb 19, 2015 | Haemonetics Corporation 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. Terminated |
JPA | K002177 |
| Jul 24, 2013 | Haemonetics Corporation TEG 5000 Thromboelastograph Coagulation Analyzer
Product Usage:
Multipurpose System for In Vitro Coagulation Studies Terminated |
JPA | K002177 |
| Aug 5, 2011 | Haemonetics Corporation 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 C Terminated |
CAC | K053000 |
| Jun 7, 2011 | Haemonetics Corporation 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,
105 Terminated |
CAC | K992723 |
| Apr 6, 2011 | Haemonetics Corporation 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 t Terminated |
KSD | None listed |
| Feb 22, 2011 | Haemonetics Corporation Haemonetics cardioPAT Cardiovascular - autotransfusion System
Catalog Number: 02050-US Terminated |
CAC | K053000 |
| Dec 8, 2007 | Haemonetics Corporation Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion) Terminated |
CAC | K053000 |
| Oct 12, 2006 | Haemonetics Corporation SmartSuction Harmony Powered Suction Device
Model Number: HAR-E-115-US Terminated |
BTA | K052626 |
| Apr 29, 2006 | Haemonetics Corporation Haemonetics Cell Saver 5+ Autogolous Blood Recovery System
Model Number: LN02005-110EP Terminated |
CAC | K014083 |
| Apr 29, 2006 | Haemonetics Corporation Haemonetics Cell Saver 5 Autogolous Blood Recovery System
Model Numbr: LN02005-110-E Terminated |
CAC | K014083 |
| Nov 23, 2005 | Haemonetics Corporation 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 Repl Terminated |
CAC | K043127 |
| Jan 30, 2003 | Haemonetics Corporation Haemonetics Cell Saver 5 Low Volume (12ml) Fast Pack with Filtered Reservoir
List Number: 265F Terminated |
CAC | K932890 |
| Jan 30, 2003 | Haemonetics Corporation Haemonetics Cell Saver 5 Low Volume (125mL) Fast Pack
List Number: 265 Terminated |
CAC | K932890 |
| Jan 30, 2003 | Haemonetics Corporation Haemonetics High Speed Cell Saver Bowl Set
List Number: 263 Terminated |
CAC | K932890 |
| Jan 30, 2003 | Haemonetics Corporation Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set
List Number: 261 Terminated |
CAC | K932890 |
| Jan 30, 2003 | Haemonetics Corporation Haemonetics Cell Saver 5 Fast Pack with Filtered Reservoir
List Number: 260F Terminated |
CAC | K932890 |
| Jan 30, 2003 | Haemonetics Corporation Haemonetics Cell Saver 5 Fast Pack
List Number: 260 Terminated |
CAC | K932890 |