# K161506: Penumbra Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Sep 26, 2016 after 117 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: 7 generations back to K010579 (2001). 22 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103405: Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction Cath, Vascular Solutions, Inc. (2010) Summary page 4.

## Most influential descendants
- K163618: INDIGO Aspiration System (2017), 2 descendants of its own
- K180412: Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (2018), 1 descendant of its own
- K220683: INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) (2022), 0 descendants of its own

## Indications for use
As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Aspiration Catheters to the Penumbra Aspiration Pump. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K161506
Methodology: https://510kreport.com/methodology