# K111380: Neuron Max System

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Jul 19, 2011 after 64 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.
61 later devices descend from it; 10 cite it directly.
4 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070970: Neuron Support Catheter System, Model 5F/6F, Penumbra, Inc. (2007) Summary page 1.
- K082290: Neuron Delivery Catheter 070, Penumbra, Inc. (2008) Summary page 1.
- K083125: Neuron Select Catheter Size 070, Penumbra, Inc. (2008) Summary page 1.

## Most influential descendants
- K180169: EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length (2018), 27 descendants of its own
- K203764: TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform (2021), 17 descendants of its own
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM (2016), 13 descendants of its own
- K222358: Indigo Aspiration System - Lightning Flash (2022), 8 descendants of its own
- K200121: Route 92 Medical 088 Access System, 110 cm (2020), 8 descendants of its own

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

Source page: https://510kreport.com/device/K111380
Methodology: https://510kreport.com/methodology