# K160449: Penumbra System, Penumbra Pump MAX

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: May 25, 2016 after 97 days
- Product code: NRY (Catheter, Thrombus Retriever)
- 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: 8 generations back to K003410 (2001). 12 ancestors in all.
31 later devices descend from it; 4 cite it directly.
5 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152541: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters, Penumbra, Inc. (2016) Summary page 4.
- K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing, Penumbra, Inc. (2012) Summary page 4.

## Most influential descendants
- K161640: Penumbra System ACE 68 Reperfusion Catheter (2016), 17 descendants of its own
- K162901: Penumbra 3D Revascularization Device (2017), 16 descendants of its own
- K173761: Penumbra System Reperfusion Catheter JET 7 (2018), 10 descendants of its own
- K173841: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm (2018), 6 descendants of its own
- K232971: APRO 55 Catheter and Alembic Aspiration Tubing (2024), 4 descendants of its own

## Indications for use
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Pump MAX. The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K160449
Methodology: https://510kreport.com/methodology