Reflow Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Reflow Medical, Inc.” (first 2010, latest 2026), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 79 days. Since 2017 the median was 96 days, against 106 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 |
|---|---|---|
| 2012 | 1 | 19 |
| 2013 | 1 | 45 |
| 2014 | 2 | 124 |
| 2015 | 1 | 29 |
| 2016 | 1 | 108 |
| 2017 | 2 | 44 |
| 2018 | 1 | 140 |
| 2019 | 1 | 79 |
| 2020 | 4 | 88 |
| 2021 | 1 | 123 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 132 |
| 2025 | 1 | 120 |
| 2026 | 1 | 74 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Reflow Medical, Inc. took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 18 | 18 |
| PDU | Catheter For Crossing Total Occlusions | 1 | 1 |
| SEU | Peripheral Temporary And Retrievable Stent System | 1 | 0 |
Review panels
- Cardiovascular (20)
Most recent Reflow Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262013 | Kiba CTO Crossing Catheter | PDU | 2026-08-28 | 74 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | DQY | 2025-08-22 | 120 |
| K233350 | SINC Support Catheter | DQY | 2024-02-08 | 132 |
| K210188 | coraCross | DQY | 2021-05-28 | 123 |
| K201811 | coraForce and coraFlex Support Catheters | DQY | 2020-10-26 | 117 |
| K200094 | speX LP Support Catheter | DQY | 2020-03-18 | 62 |
| K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | DQY | 2020-02-20 | 59 |
| K193012 | speX Support Catheter | DQY | 2020-02-19 | 113 |
| K190393 | Wingman 14C Crossing Catheter | DQY | 2019-05-09 | 79 |
| K173661 | Wingman 35 Crossing Catheter | DQY | 2018-04-18 | 140 |
9 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240048 | De Novo | Peripheral Temporary And Retrievable Stent System | 2025-05-29 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-03-22.
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 Reflow Medical, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06117150: Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY) (Active not recruiting, started 2024-06-09)
- NCT05358353: A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL) (Completed, started 2022-10-18)
- NCT04162418: A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB (Completed, started 2020-02-14)
- NCT03807531: A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee (Active not recruiting, started 2019-07-11)
- NCT03403426: ReFlow Medical Wingman Catheter Wing-IT Clinical Trial (Completed, started 2018-02-13)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reflow Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Reflow Medical, Inc.” (first 2010, latest 2026), plus 1 De Novo decision, across 3 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 Reflow Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reflow Medical, Inc. is 79 days. Since 2017: 96 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Reflow Medical, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 18); PDU (Catheter For Crossing Total Occlusions, 1); SEU (Peripheral Temporary And Retrievable Stent System, 1).
Next steps
- See all 19 Reflow Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Reflow Medical, 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.