# K260220: Route 92 Medical Full Length 046 Access System

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical, Inc.
- Decided: Sep 16, 2026 after 233 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: 12 generations back to K010954 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231583: Route 92 Medical Full Length 054 Access System, Route 92 Medical, Inc. (2023) Summary page 5.

## Indications for use
The Route 92 Medical Full Length 046 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/K260220
Methodology: https://510kreport.com/methodology