Bolton Medical, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Bolton Medical, Inc.” (first 2002, latest 2002), plus 3 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 3 | 0 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 | 1 |
Review panels
- Cardiovascular (4)
Most recent Bolton Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021996 | BOLTON PTA CATHETER | LIT | 2002-08-23 | 66 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P200045 | PMA | RelayPro Thoracic Stent-Graft System | 2021-08-05 |
| P190015 | PMA | TREO® Abdominal Stent-Graft System | 2020-05-04 |
| P110038 | PMA | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | 2012-09-21 |
Recalls
5 product recalls in 4 recall events; 5 initiated in the last five years. Most recent: 2026-04-22.
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 Bolton Medical, Inc. is the lead sponsor of 12 device studies on ClinicalTrials.gov (7 active or recruiting). Most recent:
- NCT07026877: Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA (Recruiting, started 2025-11-18)
- NCT04697784: Post-Approval Study of the TREO Abdominal Stent-Graft System (Active not recruiting, started 2021-01-20)
- NCT03033043: Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection (Active not recruiting, started 2017-12-14)
- NCT03214601: Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System (Active not recruiting, started 2017-12-04)
- NCT02818972: RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (Active not recruiting, started 2017-05-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bolton Medical, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Bolton Medical, Inc.” (first 2002, latest 2002), plus 3 PMA decisions, 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 Bolton Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bolton Medical, Inc. is 66 days.
Which FDA product codes appear under Bolton Medical, Inc.?
The most frequent FDA product codes under this applicant name are MIH (System, Endovascular Graft, Aortic Aneurysm Treatment, 3); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 1).
Next steps
- See all 1 Bolton Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MIH, Bolton Medical, 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.