# K192833: Indigo Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Dec 20, 2019 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: 8 generations back to K003410 (2001). 10 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142870: Penumbra Embolectomy Aspiration System [INDIGO Aspiration System], Penumbra, Inc. (2015) Summary page 4.

## Most influential descendants
- K220270: Aspirex Thrombectomy System (2022), 1 descendant of its own
- K242319: Indigo® Aspiration System – Aspiration Catheter 6X (2024), 0 descendants of its own
- K230356: Aspirex™ Thrombectomy System (2023), 0 descendants of its own
- K202821: Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 (2020), 0 descendants of its own
- K200771: Indigo Aspiration System Lightning Aspiration Tubing (2020), 0 descendants of its own

## Indications for use
INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K192833
Methodology: https://510kreport.com/methodology