Haemonetics Corp.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under 3 spellings of the applicant name “Haemonetics Corp.” (first 1980, latest 2025), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 154 days, against 199 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 88 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 118 |
| 2017 | 2 | 274 |
| 2018 | 0 | — |
| 2019 | 1 | 175 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 154 |
| 2023 | 0 | — |
| 2024 | 1 | 266 |
| 2025 | 2 | 29 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Haemonetics Corp. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 199 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | 18 | 18 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 5 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 3 | 3 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| CAK | Microfilter, Blood Transfusion | 1 | 1 |
| CAL | Laryngoscope, Non-Rigid | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 1 | 1 |
Review panels
- Cardiovascular (18)
- Hematology (8)
- General Hospital (5)
- General and Plastic Surgery (3)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
Most recent Haemonetics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | JPA | 2025-04-30 | 28 |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | JPA | 2025-01-15 | 30 |
| K232018 | Citrated: K, KH, RTH, FFH | JPA | 2024-03-29 | 266 |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | CAC | 2022-11-15 | 154 |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | JPA | 2019-05-09 | 175 |
| K160502 | TEG 6s Hemostasis System | JPA | 2017-04-19 | 421 |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | CAC | 2017-01-03 | 126 |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion System | CAC | 2016-05-24 | 118 |
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | CAC | 2012-10-25 | 90 |
| K120586 | CELL SAVER ELITE | CAC | 2012-05-22 | 85 |
26 earlier clearances. See the full list in Caduvo.
Recalls
46 product recalls in 17 recall events; 2 initiated in the last five years. Most recent: 2022-04-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Haemonetics Corp. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04320823: IMPACT (Improving Plasma Collection) Clinical Trial (Completed, started 2020-01-06)
- NCT02798328: Direct Oral Anticoagulant Assay Detection & Classification Study for the TEG 6S System (Completed, started 2016-08)
- NCT02476851: Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder (Completed, started 2015-06)
- NCT01756976: Clinical Evaluation of the OrthoPAT Advance System (Completed, started 2012-12)
SEC filings
HAEMONETICS CORP (HAE): EDGAR filings, CIK 313143. An SEC registrant with the same name, matched by name only.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Haemonetics Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Haemonetics Corp. (28)
- Haemonetics Corporation (7)
- Haemonetics (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Haemonetics Corp.?
FDA lists 36 510(k) clearances under 3 spellings of the applicant name “Haemonetics Corp.” (first 1980, latest 2025), across 10 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Haemonetics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Haemonetics Corp. is 72 days. Since 2017: 154 days, versus 199 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Haemonetics Corp.?
The most frequent FDA product codes under this applicant name are CAC (Apparatus, Autotransfusion, 18); JPA (System, Multipurpose For In Vitro Coagulation Studies, 5); KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components, 3).
Next steps
- See all 36 Haemonetics Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAC, Haemonetics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.