Surmodics,Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Surmodics,Inc.” (first 2018, latest 2025), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 70 days. Since 2017 the median was 70 days, against 84 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 56 |
| 2019 | 1 | 36 |
| 2020 | 1 | 356 |
| 2021 | 1 | 78 |
| 2022 | 2 | 68 |
| 2023 | 3 | 63 |
| 2024 | 1 | 120 |
| 2025 | 1 | 70 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surmodics,Inc. took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 84 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 5 | 5 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | 1 | 0 |
Review panels
- Cardiovascular (12)
Most recent Surmodics,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252227 | Pounce(TM) Sheath | DYB | 2025-09-24 | 70 |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | QEW | 2024-09-11 | 120 |
| K232647 | Microcatheter | DQY | 2023-09-29 | 29 |
| K231828 | Pounce Sheath | DYB | 2023-09-07 | 78 |
| K231022 | Pounce Thrombectomy System | QEW | 2023-06-12 | 63 |
| K221886 | Sublime Microcatheter | DQY | 2022-10-14 | 107 |
| K220501 | Pounce Thrombectomy System | QEW | 2022-03-23 | 29 |
| K211492 | Pounce Thrombectomy System | QEW | 2021-07-30 | 78 |
| K192814 | Pounce Thrombus Retrieval System | QEW | 2020-09-21 | 356 |
| K190644 | Guide Sheath | DYB | 2019-04-18 | 36 |
1 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P210025 | PMA | SurVeil Drug-Coated Balloon | 2023-06-16 |
Recalls
openFDA lists no recalls under a recalling firm named Surmodics,Inc..
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 Surmodics,Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05868161: Pounce™ Thrombectomy System Retrospective Registry (Recruiting, started 2023-04-18)
- NCT04107298: Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon (Completed, started 2020-06-29)
- NCT03734679: Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH) (Completed, started 2018-12-05)
- NCT03241459: Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (Completed, started 2017-10-23)
- NCT02648620: Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon (Completed, started 2016-04-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surmodics,Inc.?
FDA lists 11 510(k) clearances under the applicant name “Surmodics,Inc.” (first 2018, latest 2025), plus 1 PMA decision, across 4 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 Surmodics,Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surmodics,Inc. is 70 days. Since 2017: 70 days, versus 84 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Surmodics,Inc.?
The most frequent FDA product codes under this applicant name are QEW (Peripheral Mechanical Thrombectomy With Aspiration, 5); DQY (Catheter, Percutaneous, 3); DYB (Introducer, Catheter, 3).
Next steps
- See all 11 Surmodics,Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEW, Surmodics,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.