Hemotec, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Hemotec, Inc.” (first 1980, latest 1990), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 55 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOX | Analyzer, Heparin, Automated | 5 | 5 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 5 |
| JBP | Activated Whole Blood Clotting Time | 2 | 2 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 1 |
Review panels
- Hematology (14)
- Cardiovascular (1)
Most recent Hemotec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | JBP | 1990-07-03 | 56 |
| K894466 | HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS | JPA | 1989-09-05 | 49 |
| K894359 | CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS | JPA | 1989-09-05 | 53 |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | JOX | 1989-09-05 | 53 |
| K884590 | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES | KFF | 1989-01-10 | 68 |
| K875089 | HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN | JPA | 1988-03-09 | 91 |
| K880302 | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER | GGN | 1988-02-19 | 25 |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | JOX | 1985-12-04 | 35 |
| K854376 | HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS | JPA | 1985-12-04 | 35 |
| K853789 | ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR | JPA | 1985-10-04 | 24 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hemotec, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hemotec, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemotec, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Hemotec, Inc.” (first 1980, latest 1990), across 6 product codes in 2 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 Hemotec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemotec, Inc. is 55 days.
Which FDA product codes appear under Hemotec, Inc.?
The most frequent FDA product codes under this applicant name are JOX (Analyzer, Heparin, Automated, 5); JPA (System, Multipurpose For In Vitro Coagulation Studies, 5); JBP (Activated Whole Blood Clotting Time, 2).
Next steps
- See all 15 Hemotec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOX, Hemotec, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.