FreeClimb 54 x 148 cm Access System
Model Gen 1 · ROUTE 92 MEDICAL · DI 00853799007640
QJP — Catheter, Percutaneous, Neurovasculature · Class II · 21 CFR 870.1250
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.67 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 1.5 |
| 2019-04 | 0 | 1.6 |
| 2019-05 | 0 | 2.5 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1.5 |
| 2019-12 | 0 | 1.33 |
| 2020-01 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 2 |
| 2020-04 | 0 | 1.5 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.67 |
| 2020-07 | 0 | 1.33 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 2.86 |
| 2020-12 | 0 | 2.25 |
| 2021-01 | 0 | 1.75 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 2.2 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 1.25 |
| 2021-06 | 0 | 1.4 |
| 2021-07 | 0 | 1.09 |
| 2021-08 | 0 | 1.67 |
| 2021-09 | 0 | 1.03 |
| 2021-10 | 0 | 1.97 |
| 2021-11 | 0 | 1.15 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1.5 |
| 2022-02 | 0 | 1.57 |
| 2022-03 | 0 | 1.25 |
| 2022-04 | 0 | 1.5 |
| 2022-05 | 0 | 1.67 |
| 2022-06 | 0 | 3.13 |
| 2022-07 | 0 | 1.5 |
| 2022-08 | 0 | 3.67 |
| 2022-09 | 0 | 1.22 |
| 2022-10 | 0 | 1.5 |
| 2022-11 | 0 | 5.5 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 2.14 |
| 2023-02 | 0 | 2.6 |
| 2023-03 | 0 | 1.77 |
| 2023-04 | 0 | 4.14 |
| 2023-05 | 0 | 5.67 |
| 2023-06 | 0 | 3.38 |
| 2023-07 | 0 | 4.4 |
| 2023-08 | 0 | 5.33 |
| 2023-09 | 0 | 3.25 |
| 2023-10 | 0 | 8.2 |
| 2023-11 | 0 | 4.57 |
| 2023-12 | 0 | 2.8 |
| 2024-01 | 0 | 5.29 |
| 2024-02 | 0 | 4.33 |
| 2024-03 | 0 | 3.83 |
| 2024-04 | 0 | 4 |
| 2024-05 | 0 | 3 |
| 2024-06 | 0 | 3.13 |
| 2024-07 | 0 | 3 |
| 2024-08 | 0 | 3 |
| 2024-09 | 0 | 8.75 |
| 2024-10 | 0 | 5 |
| 2024-11 | 0 | 7 |
| 2024-12 | 0 | 4.8 |
| 2025-01 | 0 | 5.22 |
| 2025-02 | 0 | 2.57 |
| 2025-03 | 0 | 4.11 |
| 2025-04 | 0 | 3.1 |
| 2025-05 | 0 | 2.93 |
| 2025-06 | 0 | 4.5 |
| 2025-07 | 0 | 7 |
| 2025-08 | 0 | 8.57 |
| 2025-09 | 0 | 5.38 |
| 2025-10 | 0 | 4.4 |
| 2025-11 | 0 | 8.86 |
| 2025-12 | 0 | 5.8 |
| 2026-01 | 0 | 9.75 |
| 2026-02 | 0 | 4.43 |
| 2026-03 | 0 | 4.62 |
| 2026-04 | 0 | 5.78 |
| 2026-05 | 0 | 4.91 |
| 2026-06 | 0 | 7.38 |
Regulatory clearances
- K231583 SESE 2023-08-15 (k number procode)
Predicate lineage
K231583 — cites (transitively): K222743 (d1), K190431 (d2), K210635 (d2), K182512 (d3), K201518 (d3), K200121 (d4), K180169 (d5), K180201 (d5), K111380 (d6), K150107 (d6), K161152 (d6), K163233 (d6), K070970 (d7), K082290 (d7), K110055 (d7) — cited as predicate by K233329
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ROUTE 92 MEDICAL
Nothing in the loaded window.