Route 92 Medical, Inc.: FDA clearances and approvals
Route 92 Medical, Inc. has 15 FDA 510(k) clearances (first 2018, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 119 days. Since 2017 its median was 119 days, against 119 days for all cleared 510(k)s in the same product codes. openFDA lists 5 product recalls by a recalling firm named Route 92 Medical, Inc. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 2 | 104 |
| 2019 | 1 | 27 |
| 2020 | 4 | 78 |
| 2021 | 1 | 146 |
| 2022 | 1 | 25 |
| 2023 | 2 | 108 |
| 2024 | 2 | 214 |
| 2025 | 1 | 179 |
| 2026 | 1 | 233 |
Review time against the same product codes
Since 2017, Route 92 Medical, Inc.'s cleared 510(k)s took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | 8 | 8 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| NRY | Catheter, Thrombus Retriever | 3 | 3 |
Review panels
- Neurology (11)
- Cardiovascular (4)
Most recent Route 92 Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260220 | Route 92 Medical Full Length 046 Access System | QJP | 2026-09-16 | 233 |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set | NRY | 2025-05-19 | 179 |
| K240529 | 8F Modified Sheath System | QJP | 2024-10-02 | 222 |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set | NRY | 2024-04-23 | 207 |
| K231583 | Route 92 Medical Full Length 054 Access System | QJP | 2023-08-15 | 76 |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set | NRY | 2023-04-11 | 139 |
| K222743 | Route 92 Medical Full Length 070 Access System | QJP | 2022-10-04 | 25 |
| K210635 | Route 92 Medical Full Length 088 Access System | QJP | 2021-07-27 | 146 |
| K203043 | Route 92 Medical 070 Access System | QJP | 2020-11-11 | 36 |
| K201518 | Route 92 Medical 088 Access System | QJP | 2020-08-14 | 67 |
5 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 1 recall events; 5 initiated in the last five years. Most recent: 2024-03-08.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Route 92 Medical, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07436156: SUMMIT RISE Study of Acute Ischemic Stroke Patients (Recruiting, started 2026-02-12)
- NCT05018650: A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX) (Completed, started 2021-12-21)
- NCT05429658: Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (Completed, started 2019-09-27)
Frequently asked questions
How many FDA 510(k) clearances does Route 92 Medical, Inc. have?
Route 92 Medical, Inc. has 15 FDA 510(k) clearances (first 2018, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Route 92 Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Route 92 Medical, Inc.'s cleared 510(k)s is 119 days. Since 2017: 119 days, versus 119 days for all cleared 510(k)s in the same product codes.
What devices does Route 92 Medical, Inc. make?
Its most frequent FDA product codes are QJP (Catheter, Percutaneous, Neurovasculature, 8); DQY (Catheter, Percutaneous, 4); NRY (Catheter, Thrombus Retriever, 3).
Has Route 92 Medical, Inc. had device recalls?
openFDA lists 5 product recalls in 1 recall event by a recalling firm whose name matches Route 92 Medical, Inc; the most recent began 2024-03-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Route 92 Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QJP, Route 92 Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.