Terumo Corp.: FDA filings under this applicant name

FDA lists 34 510(k) clearances under the applicant name “Terumo Corp.” (first 1991, latest 2026), across 19 product codes in 5 review panels. Median 510(k) review time under this name: 54 days. Since 2017 the median was 174 days, against 140 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Terumo Corp. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.

Top product codes

Plus 9 more product codes.

Review panels

• Cardiovascular (22)
• General Hospital (8)
• Gastroenterology and Urology (2)
• Clinical Chemistry (1)
• Dental (1)

Most recent Terumo Corp. 510(k) clearances

24 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Terumo Corp..

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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Terumo Corp. (a text match, not an official crosswalk):

• C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)

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 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 Corp.?

FDA lists 34 510(k) clearances under the applicant name “Terumo Corp.” (first 1991, latest 2026), across 19 product codes in 5 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 Corp.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Terumo Corp. is 54 days. Since 2017: 174 days, versus 140 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Terumo Corp.?

The most frequent FDA product codes under this applicant name are DTZ (Oxygenator, Cardiopulmonary Bypass, 6); DQX (Wire, Guide, Catheter, 4); DQO (Catheter, Intravascular, Diagnostic, 3).

Next steps

• See all 34 Terumo Corp. clearances with predicates and recalls
• Run predicate analysis for product code DTZ, Terumo 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.

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