Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
POL — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
123 daysmedian FDA review time
312 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242676 | pRESET Delta Thrombectomy Device and pRESET Delta LITE Throm | Phenox Limited | 2025-02-28 | 175 | 0 |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Limited | 2023-10-21 | 144 | 0 |
| K223305 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2023-03-29 | 153 | 1 |
| K222848 | pRESET Thrombectomy Device | Phenox Limited | 2023-01-20 | 121 | 0 |
| K210502 | Trevo NXT ProVue Retriever | Stryker Neurovascular | 2021-08-27 | 186 | 0 |
| K203358 | Solitaire X Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-03-01 | 105 | 0 |
| K203219 | Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever | Stryker Neurovascular | 2020-12-29 | 57 | 0 |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Rev | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2020-11-20 | 333 | 0 |
| K200117 | Trevo NXT ProVue Retriever | Stryker | 2020-02-07 | 17 | 0 |
| K192207 | Trevo NXT ProVue Retriever | Stryker | 2019-11-22 | 100 | 0 |
| K190779 | Trevo XP ProVue Retriever | Stryker | 2019-06-25 | 90 | 1 |
| K181807 | Solitaire 2 Revascularization Device, Solitaire Platinum Rev | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-03-06 | 243 | 0 |
| K183022 | Solitaire 4 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-01-29 | 89 | 0 |
| K181186 | Solitare Platinum Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-25 | 175 | 0 |
| K181060 | Solitaire 2 and Solitaire Platinum Revascularization Device | Medtronic Neurovascular | 2018-08-24 | 123 | 0 |
| K173352 | Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trev | Concentric Medical, Inc. | 2018-02-15 | 113 | 1 |
| K162539 | Solitaire 2 Revascularization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-11-10 | 59 | 0 |
| DEN150049 | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4 | Concentric Medical, Inc. | 2016-09-02 | 312 | 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