# K182512: Route 92 Medical Delivery Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Route 92 Medical, Inc.
- Decided: Dec 10, 2018 after 89 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K240711: Zipline Access Catheter (2024), 0 descendants of its own
- K190431: Route 92 Medical Delivery Catheter (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K182512
Methodology: https://510kreport.com/methodology