Terumobct, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Terumobct, Inc.” (first 2013, latest 2019), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 150 days. Since 2017 the median was 181 days, against 185 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.
Caduvo groups this applicant name under Terumo, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 90 |
| 2014 | 0 | — |
| 2015 | 1 | 249 |
| 2016 | 1 | 29 |
| 2017 | 1 | 177 |
| 2018 | 2 | 190 |
| 2019 | 1 | 91 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Terumobct, Inc. took a median 181 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 185 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 7 | 7 |
| KCY | Tourniquet, Pneumatic | 1 | 1 |
Review panels
Most recent Terumobct, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183081 | Spectra Optia Apheresis System | LKN | 2019-02-05 | 91 |
| K181049 | Spectra Optia Apheresis System | LKN | 2018-11-01 | 195 |
| K172590 | Spectra Optia Apheresis System | LKN | 2018-03-02 | 185 |
| K162365 | T-Cuff | KCY | 2017-02-16 | 177 |
| K153601 | Spectra Optia Apheresis System | LKN | 2016-01-14 | 29 |
| K141938 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) | LKN | 2015-03-23 | 249 |
| K132429 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET | LKN | 2013-12-06 | 123 |
| K131744 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE | LKN | 2013-08-08 | 56 |
Recalls
openFDA lists no recalls under a recalling firm named Terumobct, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Terumobct, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Terumobct, Inc.” (first 2013, latest 2019), across 2 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 Terumobct, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terumobct, Inc. is 150 days. Since 2017: 181 days, versus 185 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Terumobct, Inc.?
The most frequent FDA product codes under this applicant name are LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic, 7); KCY (Tourniquet, Pneumatic, 1).
Next steps
- See all 8 Terumobct, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKN, Terumobct, 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.