# Haemonetics Corp.

- Location (FDA's records): Braintree, MA
- FDA decisions: 36 (1980–2025): 36 510(k) clearances
- Names in FDA's records: Haemonetics Corp. (28); Haemonetics Corporation (7); Haemonetics (1)
- Product codes: CAC (18), JPA (5), KSR (3), FPA (2), FRN (2), BTA (2), LKN (1), CAL (1), CAK (1), GAA (1)
- 510(k) review time since 2016: median 103 days, against 74 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 12 (10 its own)
- Recalls linked to its devices: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coramed Technologies, LLC: 3 (https://510kreport.com/company/coramed-technologies)
- Haemoscope Corp.: 2 (https://510kreport.com/company/haemoscope)
- Cobe Laboratories, Inc.: 1 (https://510kreport.com/company/cobe-laboratories)
- Medela AG: 1 (https://510kreport.com/company/medela)
- Level 1 Technologies, Inc.: 1 (https://510kreport.com/company/level-1-technologies)
- Transfusion Technologies Corp.: 1 (https://510kreport.com/company/transfusion-technologies)

## Firms that cite its devices most
- Fresenius Hemotechnology, Inc.: 1 (https://510kreport.com/company/fresenius-hemotechnology)
- Belmont Instrument Corp.: 1 (https://510kreport.com/company/belmont-instrument)

## Its most-cited devices
- K802674: Reservoir for Autologous Blood Transfus. (1981), cited by 1
- K162423: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (2017), cited by 1
- K883934: Cell Saver Haemolite B Auto. Blood Recovery System (1988), cited by 1
- K052626: Smartsuction Harmony Device (2005), cited by 1
- K932890: Cell Saver 5 System (1994), cited by 1
- K043127: Haemonetics Cardiovascular Perioperative Autotransfusion System (2005), cited by 1

## Recent decisions
- K251024: TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (Apr 30, 2025)
- K243858: TEG 6s Hemostasis System Citrated: K, KH, RT,  FF Assay Cartridge (Jan 15, 2025)
- K232018: Citrated: K, KH, RTH, FFH (Mar 29, 2024)
- K221722: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (Nov 15, 2022)
- K183160: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (May 9, 2019)
- K160502: TEG 6s Hemostasis System (Apr 19, 2017)
- K162423: Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (Jan 3, 2017)
- K160197: Haemonetics Cell Saver Elite Autotransfusion System (May 24, 2016)

Source page: https://510kreport.com/company/haemonetics