# K121917: Penumbra Embolectomy Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Sep 19, 2012 after 79 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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). 8 ancestors in all.
43 later devices descend from it; 1 cites it directly.
0 of 52 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.
- K113163: Penumbra System Max, Penumbra, Inc. (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K100691: Omni V SBRT Positioning System, Model RT-4500, Bionix Development Corp. (2010). Our reading of the summary gave K100691, FDA’s number for Omni V SBRT Positioning System, Model RT-4500 (Bionix Development Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Merit Embolectomy Catheter”. Kept off the family tree.

## Most influential descendants
- K142870: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (2015), 42 descendants of its own
- K160533: Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) (2016), 27 descendants of its own
- K161523: INDIGO Aspiration System (2016), 26 descendants of its own
- K180105: Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister (2018), 22 descendants of its own
- K180939: Indigo Aspiration System - Modified 110 Aspiration Tubing (2018), 21 descendants of its own

## Indications for use
The Penumbra Embolectomy Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial system. Not for use in the coronaries, the venous system or the neurovasculature.

Source page: https://510kreport.com/device/K121917
Methodology: https://510kreport.com/methodology