Terumo Cardiovascular Systems Corp.: FDA filings under this applicant name
FDA lists 74 510(k) clearances under the applicant name “Terumo Cardiovascular Systems Corp.” (first 2000, latest 2024), across 20 product codes in 4 review panels. Median 510(k) review time under this name: 81 days. Since 2017 the median was 149 days, against 113 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 |
|---|---|---|
| 2012 | 3 | 53 |
| 2013 | 3 | 30 |
| 2014 | 7 | 196 |
| 2015 | 10 | 61 |
| 2016 | 2 | 60 |
| 2017 | 2 | 98 |
| 2018 | 3 | 88 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 672 |
| 2022 | 0 | — |
| 2023 | 1 | 292 |
| 2024 | 1 | 125 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Terumo Cardiovascular Systems Corp. took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 12 | 12 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 10 | 10 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 7 | 7 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 6 | 6 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 6 | 6 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 6 | 6 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 4 | 4 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 4 | 4 |
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | 3 | 3 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 3 | 3 |
Plus 10 more product codes.
Review panels
Most recent Terumo Cardiovascular Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234065 | CDI OneView Monitoring System | DRY | 2024-04-25 | 125 |
| K221895 | Terumo Advanced Perfusion System 1 | DTQ | 2023-04-18 | 292 |
| K200091 | Capiox iCP Centrifugal Pump | KFM | 2021-11-18 | 672 |
| K182110 | CDI Blood Parameter Monitoring System 550 | DRY | 2018-11-02 | 88 |
| K180950 | Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) | DTZ | 2018-06-22 | 72 |
| K172071 | Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) | DTZ | 2018-03-29 | 262 |
| K172220 | Advanced Perfusion System 1 | DTQ | 2017-08-17 | 24 |
| K163531 | Advanced Perfusion System 1 | DTQ | 2017-06-07 | 173 |
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 | DWB | 2016-11-17 | 37 |
| K160206 | VirtuoSaph Plus Endoscopic Vessel Harvesting System | GEI | 2016-04-21 | 84 |
64 earlier clearances. See the full list in Caduvo.
Recalls
571 product recalls in 173 recall events; 7 initiated in the last five years. Most recent: 2025-05-28.
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.
- Terumo Medical Corp. (157 510(k)s)
- Terumo Corp. (34 510(k)s)
- Terumo America, Inc. (31 510(k)s)
- Terumo Europe N.V. (28 510(k)s)
- Terumo (Philippines) Corporation (5 510(k)s)
- Terumo Medical Products (Hangzhou) Co., Ltd. (4 510(k)s)
- Terumo Bct (1 510(k)s)
- Terumo Cardiovascular Systems Thi Plant (1 510(k)s)
- Terumo Clinical Supply Co., Ltd. (1 510(k)s)
- Terumo Medical Coporation (1 510(k)s)
- Terumo Medical Products Hangzhou Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Terumo Cardiovascular Systems Corp.?
FDA lists 74 510(k) clearances under the applicant name “Terumo Cardiovascular Systems Corp.” (first 2000, latest 2024), across 20 product codes in 4 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 Terumo Cardiovascular Systems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terumo Cardiovascular Systems Corp. is 81 days. Since 2017: 149 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Terumo Cardiovascular Systems Corp.?
The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 12); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 10); DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 7).
Next steps
- See all 74 Terumo Cardiovascular Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code DTZ, Terumo Cardiovascular Systems 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, 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.