# K072718: Penumbra System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Dec 28, 2007 after 94 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003410 (2001). 4 ancestors in all.
120 later devices descend from it; 7 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)
- K033736: Merci Retriever, Models 90065, 90066, Concentric Medical, Inc. (2004) Summary page 1.
- K003086: Concentric Micro Catheter, Models 90001 to 90008, Concentric Medical, Inc. (2001) Summary page 1.

## 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

## Recalls of this device
- Oct 25, 2010 · Not classified · Z-0428-2011: Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.

## 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 (in the internal carotid, middle cerebral - MI and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.

Source page: https://510kreport.com/device/K072718
Methodology: https://510kreport.com/methodology