# K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Sep 21, 2009 after 185 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
No predicates in its family tree.
121 later devices descend from it; 11 cite it directly.
6 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Penumbra System: named in the summary without a submission number
- (no number) Neuro Intracranial Access System: named in the summary without a submission number

## Most influential descendants
- K100769: Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054 (2010), 118 descendants of its own
- 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

## Indications for use
The Penumbra SystemTM is 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/K090752
Methodology: https://510kreport.com/methodology