# K192981: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: May 28, 2020 after 217 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.
12 later devices descend from it; 4 cite it directly.
0 of 23 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
- K222358: Indigo Aspiration System - Lightning Flash (2022), 8 descendants of its own
- K240030: Indigo® Aspiration System - Lightning® Flash (2024), 2 descendants of its own
- K252956: Helo Thrombectomy System (2025), 1 descendant of its own
- K232679: Cleaner™ Pro Thrombectomy System; Cleaner™ Pro Aspiration Catheter with Handpiece; Cleaner™ Pro Aspiration Canister (2024), 1 descendant of its own
- K261800: Helo Max Thrombectomy System (HEL2090) (2026), 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. 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/K192981
Methodology: https://510kreport.com/methodology