Terumo Europe N.V.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Terumo Europe N.V.” (first 1999, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 197 days, against 178 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 | 0 | — |
| 2013 | 1 | 50 |
| 2014 | 2 | 68 |
| 2015 | 2 | 43 |
| 2016 | 0 | — |
| 2017 | 1 | 245 |
| 2018 | 0 | — |
| 2019 | 1 | 71 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 412 |
| 2023 | 1 | 197 |
| 2024 | 0 | — |
| 2025 | 3 | 141 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Terumo Europe N.V. took a median 197 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 178 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 15 | 15 |
| FPA | Set, Administration, Intravascular | 7 | 7 |
| FMF | Syringe, Piston | 4 | 4 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| QYM | Ophthalmic Needle | 1 | 1 |
Review panels
- General Hospital (27)
- Clinical Chemistry (1)
Most recent Terumo Europe N.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | FMI | 2025-07-08 | 60 |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) | FMI | 2025-05-29 | 220 |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) | FMI | 2025-04-04 | 141 |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M) | QYM | 2023-10-18 | 197 |
| K212095 | SurGuard3 Safety Hypodermic Needle | FMI | 2022-08-22 | 412 |
| K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall | FMI | 2019-10-11 | 71 |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH | FMF | 2017-02-10 | 245 |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | FMI | 2015-06-25 | 30 |
| K150263 | K-Pack II Needle-21G x 2 | FMI | 2015-04-01 | 56 |
| K133894 | SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) | FPA | 2014-03-18 | 88 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Terumo Europe N.V..
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.
Device clinical trials
An industry sponsor named Terumo Europe N.V. is the lead sponsor of 15 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT05911633: BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC) (Recruiting, started 2024-02-27)
- NCT05705973: Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients (Active not recruiting, started 2023-04-25)
- NCT05111795: Holmium-166 Retrospective Collection of Real-World Data (Completed, started 2022-01-17)
- NCT05027698: Post-Market Clinical Investigation of the FemoSeal™ VCS: A Prospective, Multi-Center Observational European Study (Completed, started 2021-12-27)
- NCT04546477: Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease (Active not recruiting, started 2020-07-30)
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 America, Inc. (31 510(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 Europe N.V.?
FDA lists 28 510(k) clearances under the applicant name “Terumo Europe N.V.” (first 1999, latest 2025), across 5 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 Terumo Europe N.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terumo Europe N.V. is 88 days. Since 2017: 197 days, versus 178 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Terumo Europe N.V.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 15); FPA (Set, Administration, Intravascular, 7); FMF (Syringe, Piston, 4).
Next steps
- See all 28 Terumo Europe N.V. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Terumo Europe N.V.'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.