# K100769: Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: May 21, 2010 after 64 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: 4 generations back to K003410 (2001). 6 ancestors in all.
118 later devices descend from it; 4 cite it directly.
6 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054, Penumbra, Inc. (2009) Summary page 2.
- K072718: Penumbra System, Penumbra, Inc. (2007) Summary page 1.

## Most influential descendants
- K113163: Penumbra System Max (2011), 116 descendants of its own
- K133317: Penumbra System / Penumbra System Max (2014), 61 descendants of its own
- 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
- K121917: Penumbra Embolectomy Aspiration System (2012), 43 descendants of its own

## Indications for use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in 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/K100769
Methodology: https://510kreport.com/methodology