Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reflow Medical, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
251 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 | 120 | 0 |
| DEN240048 | Spur Peripheral Retrievable Stent System | Reflow Medical, Inc. | 2025-05-29 | 251 | 0 |
| K233350 | SINC Support Catheter | Reflow Medical, Inc. | 2024-02-08 | 132 | 0 |
| K201811 | coraForce and coraFlex Support Catheters | Reflow Medical, Inc. | 2020-10-26 | 117 | 0 |
| K190393 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | 2019-05-09 | 79 | 0 |
| K173661 | Wingman 35 Crossing Catheter | Reflow Medical, Inc. | 2018-04-18 | 140 | 0 |
| K173662 | speX Support Catheter | Reflow Medical, Inc. | 2017-12-20 | 21 | 0 |
| K170996 | Wingman 14C Crossing Catheter | Reflow Medical, Inc. | 2017-06-09 | 67 | 0 |
| K160848 | Wingman 18 Crossing Catheter | Reflow Medical, Inc. | 2016-07-14 | 108 | 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