# K231583: Route 92 Medical Full Length 054 Access System

- Pathway: 510(k) (Special)
- Applicant: Route 92 Medical, Inc.
- Decided: Aug 15, 2023 after 76 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: 11 generations back to K010954 (2001). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222743: Route 92 Medical Full Length 070 Access System, Route 92 Medical, Inc. (2022) Summary page 4.

## Most influential descendants
- K260220: Route 92 Medical Full Length 046 Access System (2026), 0 descendants of its own

## Indications for use
The Route 92 Medical Full Length 054 Access System 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/K231583
Methodology: https://510kreport.com/methodology