# K142321: Benchmark Intracranial Access System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Jan 26, 2015 after 160 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: 5 generations back to K010954 (2001). 7 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082290: Neuron Delivery Catheter 070, Penumbra, Inc. (2008) Summary page 4.
- K083125: Neuron Select Catheter Size 070, Penumbra, Inc. (2008) Summary page 4.

## Most influential descendants
- K212838: Benchmark Intracranial Access System (2022), 7 descendants of its own
- K200417: RIST Radial Access Catheter (2020), 3 descendants of its own
- K181000: SelectFlex 072 Neurovascular Access System (2018), 3 descendants of its own
- K221822: BENCHMARK BMX81 Access System (2022), 2 descendants of its own
- K201682: RIST Radial Access Catheter (2020), 2 descendants of its own

## Indications for use
The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature

Source page: https://510kreport.com/device/K142321
Methodology: https://510kreport.com/methodology