# K221822: BENCHMARK BMX81 Access System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Nov 4, 2022 after 134 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). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212838: Benchmark Intracranial Access System, Penumbra, Inc. (2022) Summary page 4.

## Most influential descendants
- K234074: Next Generation Access Catheter (2024), 1 descendant of its own
- K254223: Next Generation 088 Catheter (2026), 0 descendants of its own

## Indications for use
The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K221822
Methodology: https://510kreport.com/methodology