Gambro Bct, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Gambro Bct, Inc.” (first 2007, latest 2007), plus 1 PMA decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 107 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Terumo, based on public ownership records.
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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 2 | 1 |
Review panels
Most recent Gambro Bct, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071079 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 | LKN | 2007-08-02 | 107 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810023 | PMA | COBE CENTRY(R) TPE SYSTEM | 1982-03-16 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-09-18.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Gambro, Inc. (87 510(k)s)
- Gambro Renal Products (37 510(k)s)
- Gambro Healthcare (13 510(k)s)
- Gambro-Hospal, Inc. (3 510(k)s)
- Gambro Renal Care Products (2 510(k)s)
- Gambro-Hosp-Cobe, Inc. (1 510(k)s)
- Gambro Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Gambro Bct, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Gambro Bct, Inc.” (first 2007, latest 2007), plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Gambro Bct, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gambro Bct, Inc. is 107 days.
Which FDA product codes appear under Gambro Bct, Inc.?
The most frequent FDA product codes under this applicant name are LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic, 2).
Next steps
- See all 1 Gambro Bct, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKN, Gambro Bct, 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 (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.