Terumo Medical Corp.: FDA clearances and approvals
Terumo Medical Corp. has 157 FDA 510(k) clearances (first 1980, latest 2023), plus 3 PMA decisions, across 60 product codes in 11 review panels. Median 510(k) review time: 64 days. Since 2017 its median was 85 days, against 148 days for all cleared 510(k)s in the same product codes. openFDA lists 44 product recalls by a recalling firm named Terumo Medical Corp. It is the industry lead sponsor of 7 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 76 |
| 2013 | 1 | 189 |
| 2014 | 1 | 105 |
| 2015 | 3 | 108 |
| 2016 | 0 | — |
| 2017 | 2 | 96 |
| 2018 | 2 | 113 |
| 2019 | 0 | — |
| 2020 | 1 | 55 |
| 2021 | 1 | 45 |
| 2022 | 0 | — |
| 2023 | 1 | 106 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Terumo Medical Corp.'s cleared 510(k)s took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 27 | 27 |
| DQX | Wire, Guide, Catheter | 11 | 11 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 10 | 10 |
| FMF | Syringe, Piston | 10 | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 6 | 6 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 6 | 6 |
| FPA | Set, Administration, Intravascular | 6 | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 5 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 4 | 4 |
Plus 50 more product codes.
Review panels
- Cardiovascular (80)
- General Hospital (34)
- Gastroenterology and Urology (19)
- Clinical Chemistry (16)
- Anesthesiology (4)
- General and Plastic Surgery (2)
- Dental (1)
- Immunology (1)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
- Clinical Toxicology (1)
Most recent Terumo Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231044 | R2P Navicross | DQY | 2023-07-27 | 106 |
| K213531 | TR BAND Radial Compression Device | DXC | 2021-12-20 | 45 |
| K193125 | R2P Destination Slender Guiding Sheath | DYB | 2020-01-06 | 55 |
| K181237 | Glidesheath Slender Tibial Pedal Kit | DYB | 2018-08-03 | 85 |
| K173831 | Glidesheath Slender | DYB | 2018-05-08 | 141 |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | DYB | 2017-11-21 | 55 |
| K171491 | R2P Destination Slender Guiding Sheath | DYB | 2017-10-05 | 136 |
| K152173 | Glidesheath | DYB | 2015-12-01 | 119 |
| K152525 | TR BAND Radial Compression Device | DXC | 2015-11-10 | 68 |
| K151471 | Radifocus Glidewire Endoscopic Wire | OCY | 2015-09-17 | 108 |
147 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210017 | PMA | Cross-Seal Suture-Mediated Vascular Closure Device System | 2023-09-26 |
| P140002 | PMA | MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM | 2015-05-22 |
| P930038 | PMA | Angio Seal Vascular Closure Device | 1996-09-30 |
Recalls
44 product recalls in 15 recall events; 1 initiated in the last five years. Most recent: 2026-06-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Terumo Medical Corp. is the industry lead sponsor of 7 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05873452: Kaitoh Atherectomy FIH (Completed, started 2023-08-07)
- NCT02793492: Misago® RX Self-expanding Peripheral Stent for Common and/or External Iliac Artery (Active not recruiting, started 2022-08-30)
- NCT04371861: Observational Study to Assess Transradial Access for Treatment in the Lower Extremities. (Completed, started 2020-06-29)
- NCT04272216: An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres (Completed, started 2020-02-06)
- NCT03756558: Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System (Completed, started 2019-08-09)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Terumo Medical Corp.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Terumo Medical Corp. have?
Terumo Medical Corp. has 157 FDA 510(k) clearances (first 1980, latest 2023), plus 3 PMA decisions, across 60 product codes in 11 review panels.
How long does FDA take to clear Terumo Medical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Terumo Medical Corp.'s cleared 510(k)s is 64 days. Since 2017: 85 days, versus 148 days for all cleared 510(k)s in the same product codes.
What devices does Terumo Medical Corp. make?
Its most frequent FDA product codes are DYB (Introducer, Catheter, 27); DQX (Wire, Guide, Catheter, 11); DTZ (Oxygenator, Cardiopulmonary Bypass, 10).
Has Terumo Medical Corp. had device recalls?
openFDA lists 44 product recalls in 15 recall events by a recalling firm whose name matches Terumo Medical Corp; the most recent began 2026-06-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 157 Terumo Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Terumo Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.