# K161523: INDIGO Aspiration System

- Pathway: 510(k) (Special)
- Applicant: Penumbra, Inc.
- Decided: Jul 1, 2016 after 29 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: 9 generations back to K003410 (2001). 11 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160533: Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System), Penumbra, Inc. (2016) Summary page 5.

## Most influential descendants
- 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
- K193244: Indigo Aspiration System – Lightning Aspiration Tubing (2020), 14 descendants of its own
- K210323: Indigo Aspiration System - Lightning Aspiration Tubing (2021), 11 descendants of its own
- K222358: Indigo Aspiration System - Lightning Flash (2022), 8 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. 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 Pump MAX. Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K161523
Methodology: https://510kreport.com/methodology