# K191717: Route 92 Medical Sheath System

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical, Inc.
- Decided: Jan 13, 2020 after 201 days
- Product code: DQY (Catheter, Percutaneous)
- 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). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM, Tni Manufacturing, Inc. (2016) Summary page 4.

## Most influential descendants
- K242376: Next Generation Access Platform (2024), 0 descendants of its own
- K240529: 8F Modified Sheath System (2024), 0 descendants of its own

## Indications for use
The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Source page: https://510kreport.com/device/K191717
Methodology: https://510kreport.com/methodology