# K200121: Route 92 Medical 088 Access System, 110 cm

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical, Inc.
- Decided: Apr 18, 2020 after 88 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: 7 generations back to K010954 (2001). 14 ancestors in all.
8 later devices descend from it; 2 cite it directly.
2 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180201: Route 92 Medical Access System, Route 92 Medical, Inc. (2018) Summary page 4.
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length, Imperative Care, Inc. (2018) Summary page 4.

## Most influential descendants
- K201518: Route 92 Medical 088 Access System (2020), 5 descendants of its own
- 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
- K242051: VersaD Delivery Catheter (2025), 1 descendant of its own
- K231583: Route 92 Medical Full Length 054 Access System (2023), 1 descendant of its own

## Indications for use
The Route 92 Medical 088 Access System, 110 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/K200121
Methodology: https://510kreport.com/methodology