# K133317: Penumbra System / Penumbra System Max

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: May 13, 2014 after 197 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: 5 generations back to K003410 (2001). 7 ancestors in all.
61 later devices descend from it; 2 cite it directly.
6 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072718: Penumbra System, Penumbra, Inc. (2007) Summary page 1.
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054, Penumbra, Inc. (2009) Summary page 1.
- K100769: Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054, Penumbra, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K113163: Penumbra System Max, Penumbra, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K142458: Penumbra System ACE (2015), 60 descendants of its own
- K152541: Penumbra System ACE 64 and ACE 68 Reperfusion Catheters (2016), 54 descendants of its own
- K160449: Penumbra System, Penumbra Pump MAX (2016), 31 descendants of its own
- K161640: Penumbra System ACE 68 Reperfusion Catheter (2016), 17 descendants of its own
- K162901: Penumbra 3D Revascularization Device (2017), 16 descendants of its own

## Indications for use
The Penumbra System / Penumbra System MAX are intended 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.

Source page: https://510kreport.com/device/K133317
Methodology: https://510kreport.com/methodology