Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reflow Medical — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
138 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210188 | coraCross | Reflow Medical | 2021-05-28 | 123 | 0 |
| K200094 | speX LP Support Catheter | Reflow Medical | 2020-03-18 | 62 | 0 |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020-02-20 | 59 | 0 |
| K193012 | speX Support Catheter | Reflow Medical | 2020-02-19 | 113 | 0 |
| K151880 | Wingman Crossing Catheter | Reflow Medical | 2015-08-07 | 29 | 0 |
| K141649 | SPEX SUPPORT CATHETER | Reflow Medical | 2014-11-05 | 138 | 0 |
| K141547 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2014-09-30 | 111 | 1 |
| K132420 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2013-09-19 | 45 | 0 |
| K120178 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2012-02-08 | 19 | 0 |
| K101479 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | Reflow Medical | 2010-08-11 | 75 | 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