Terumo America, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Terumo America, Inc.” (first 1976, latest 1981), across 22 product codes in 6 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | 5 | 5 |
| FMI | Needle, Hypodermic, Single Lumen | 3 | 3 |
| FIE | Needle, Fistula | 2 | 2 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 1 | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| FKJ | Filter, Blood, Dialysis | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
Plus 12 more product codes.
Review panels
- Gastroenterology and Urology (13)
- General Hospital (11)
- Hematology (2)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Terumo America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811523 | PLASMA FLEX | KSR | 1981-09-09 | 103 |
| K802970 | TERUMO HOLLOW FIBER OXYGENATOR | DTZ | 1981-01-22 | 62 |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | FJI | 1980-12-18 | 72 |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | FJI | 1980-12-18 | 105 |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | FJI | 1980-08-12 | 85 |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | KDJ | 1980-08-12 | 85 |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | FJI | 1980-08-12 | 85 |
| K791411 | COAXIAL DUAL FLOW CATHETER | KOC | 1979-11-13 | 109 |
| K791173 | SURFLO INJECTION PLUG | FPA | 1979-07-30 | 35 |
| K790105 | TERUMO IMUGARD | GKT | 1979-05-24 | 128 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Terumo America, 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.
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 Cardiovascular Systems Corp. (74 510(k)s)
- Terumo Corp. (34 510(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 America, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Terumo America, Inc.” (first 1976, latest 1981), across 22 product codes in 6 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 America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terumo America, Inc. is 35 days.
Which FDA product codes appear under Terumo America, Inc.?
The most frequent FDA product codes under this applicant name are FJI (Dialyzer, Capillary, Hollow Fiber, 5); FMI (Needle, Hypodermic, Single Lumen, 3); FIE (Needle, Fistula, 2).
Next steps
- See all 31 Terumo America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FJI, Terumo America, 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.