Terumo (Philippines) Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Terumo (Philippines) Corporation” (first 2012, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 105 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 | 3 | 105 |
| 2013 | 0 | — |
| 2014 | 1 | 230 |
| 2015 | 1 | 57 |
| 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Terumo (Philippines) Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | FMI | 2015-10-16 | 57 |
| K133280 | TERUMO SURFLO I.V. CATHETER | FOZ | 2014-06-12 | 230 |
| K121607 | TERUMO(R) NEEDLE | FMI | 2012-11-08 | 160 |
| K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | 2012-08-28 | 32 |
| K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE | FMI | 2012-03-05 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Terumo (Philippines) Corporation.
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 America, Inc. (31 510(k)s)
- Terumo Europe N.V. (28 510(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 (Philippines) Corporation?
FDA lists 5 510(k) clearances under the applicant name “Terumo (Philippines) Corporation” (first 2012, latest 2015), across 2 product codes 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 Terumo (Philippines) Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terumo (Philippines) Corporation is 105 days.
Which FDA product codes appear under Terumo (Philippines) Corporation?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 4); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 1).
Next steps
- See all 5 Terumo (Philippines) Corporation clearances with predicates and recalls
- Run predicate analysis for product code FMI, Terumo (Philippines) Corporation'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.