# K201271: Benchmark BMX96 Access System

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Jun 11, 2020 after 30 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: 6 generations back to K010954 (2001). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 4.

## Most influential descendants
- K213390: Benchmark BMX96 Access System (2022), 0 descendants of its own

## Indications for use
The Benchmark BMX96 System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K201271
Methodology: https://510kreport.com/methodology