Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surmodics,Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
120 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252227 | Pounce(TM) Sheath | Surmodics,Inc. | 2025-09-24 | 70 | 0 |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Surmodics,Inc. | 2024-09-11 | 120 | 0 |
| K232647 | Microcatheter | Surmodics,Inc. | 2023-09-29 | 29 | 0 |
| K231828 | Pounce™ Sheath | Surmodics,Inc. | 2023-09-07 | 78 | 0 |
| K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023-06-12 | 63 | 0 |
| K221886 | Sublime Microcatheter | Surmodics,Inc. | 2022-10-14 | 107 | 0 |
| K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022-03-23 | 29 | 0 |
| K211492 | Pounce Thrombectomy System | Surmodics,Inc. | 2021-07-30 | 78 | 0 |
| K192814 | Pounce Thrombus Retrieval System | Surmodics,Inc. | 2020-09-21 | 356 | 0 |
| K190644 | Guide Sheath | Surmodics,Inc. | 2019-04-18 | 36 | 0 |
| K173560 | Microcatheter | Surmodics,Inc. | 2018-01-12 | 56 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda