# K201518: Route 92 Medical 088 Access System

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical
- Decided: Aug 14, 2020 after 67 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010954 (2001). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200121: Route 92 Medical 088 Access System, 110 cm, Route 92 Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K210635: Route 92 Medical Full Length 088 Access System (2021), 3 descendants of its own
- K222743: Route 92 Medical Full Length 070 Access System (2022), 2 descendants of its own
- K231583: Route 92 Medical Full Length 054 Access System (2023), 1 descendant of its own
- K260220: Route 92 Medical Full Length 046 Access System (2026), 0 descendants of its own
- K203043: Route 92 Medical 070 Access System (2020), 0 descendants of its own

## Indications for use
The Route 92 Medical 088 Access System, 143 cm, is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

Source page: https://510kreport.com/device/K201518
Methodology: https://510kreport.com/methodology