Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Route 92 Medical, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
207 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration T | Route 92 Medical, Inc. | 2025-05-19 | 179 | 0 |
| K240529 | 8F Modified Sheath System | Route 92 Medical, Inc. | 2024-10-02 | 222 | 0 |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspi | Route 92 Medical, Inc. | 2024-04-23 | 207 | 0 |
| K231583 | Route 92 Medical Full Length 054 Access System | Route 92 Medical, Inc. | 2023-08-15 | 76 | 0 |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspi | Route 92 Medical, Inc. | 2023-04-11 | 139 | 1 |
| K222743 | Route 92 Medical Full Length 070 Access System | Route 92 Medical, Inc. | 2022-10-04 | 25 | 1 |
| K210635 | Route 92 Medical Full Length 088 Access System | Route 92 Medical, Inc. | 2021-07-27 | 146 | 0 |
| K203043 | Route 92 Medical 070 Access System | Route 92 Medical, Inc. | 2020-11-11 | 36 | 1 |
| K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Inc. | 2020-04-18 | 88 | 0 |
| K191717 | Route 92 Medical Sheath System | Route 92 Medical, Inc. | 2020-01-13 | 201 | 0 |
| K190431 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | 2019-03-21 | 27 | 1 |
| K182512 | Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. | 2018-12-10 | 89 | 0 |
| K180201 | Route 92 Medical Access System | Route 92 Medical, Inc. | 2018-05-23 | 119 | 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