# K142458: Penumbra System ACE

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: May 22, 2015 after 262 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: 6 generations back to K003410 (2001). 9 ancestors in all.
60 later devices descend from it; 4 cite it directly.
6 of 70 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 4.
- K090752: Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator 054), Model PSS054, Penumbra, Inc. (2009) Summary page 4.
- K100769: Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054, Penumbra, Inc. (2010) Summary page 4.
- K113163: Penumbra System Max, Penumbra, Inc. (2011) Summary page 4.
- K133317: Penumbra System / Penumbra System Max, Penumbra, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K161064: Penumbra System ACE 68 Reperfusion Catheter (2016), 15 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 (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. The Reperfusion Catheters ACE 64 and ACE 68 are intended for use in revascularization within the Internal Carotid Artery (ICA) within 8 hours of symptom onset.

Source page: https://510kreport.com/device/K142458
Methodology: https://510kreport.com/methodology