Kabivitrum, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Kabivitrum, Inc.” (first 1981, latest 1988), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 3 | 3 |
| DDX | Plasminogen, Antigen, Antiserum, Control | 1 | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| LGP | Assay, Alpha-2-Antiplasmin | 1 | 1 |
Review panels
- Hematology (7)
- General Hospital (1)
Most recent Kabivitrum, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K884058 | COATEST PROTEIN C | GGP | 1988-12-13 | 78 |
| K854572 | COATEST PLASMINOGEN | DDX | 1986-02-26 | 104 |
| K844664 | THE I.V. BAG | KPE | 1985-05-06 | 157 |
| K833892 | COATEST FACTOR VIII | GGP | 1984-01-30 | 82 |
| K833891 | COATEST HEPARIN | KFF | 1984-01-30 | 82 |
| K833890 | COATEST ANTIPLASMIN | LGP | 1984-01-30 | 82 |
| K832114 | COATEST FACTOR X | GGP | 1983-08-26 | 57 |
| K812829 | COATEST ANTITHROMBIN | JBQ | 1981-12-30 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Kabivitrum, 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 Kabivitrum, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Kabivitrum, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Kabivitrum, Inc.” (first 1981, latest 1988), 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 Kabivitrum, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kabivitrum, Inc. is 82 days.
Which FDA product codes appear under Kabivitrum, Inc.?
The most frequent FDA product codes under this applicant name are GGP (Test, Qualitative And Quantitative Factor Deficiency, 3); DDX (Plasminogen, Antigen, Antiserum, Control, 1); JBQ (Antithrombin Iii Quantitation, 1).
Next steps
- See all 8 Kabivitrum, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGP, Kabivitrum, 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.