# K222358: Indigo Aspiration System - Lightning Flash

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Dec 20, 2022 after 138 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: 14 generations back to K003410 (2001). 25 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210323: Indigo Aspiration System - Lightning Aspiration Tubing, Penumbra, Inc. (2021) Summary page 5.
- K192981: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12, Penumbra, Inc. (2020) Summary page 5.
- K111380: Neuron Max System, Penumbra, Inc. (2011) Summary page 5.

## Most influential descendants
- 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
- K260028: CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister (2026), 0 descendants of its own

## Indications for use
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. 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. The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.

Source page: https://510kreport.com/device/K222358
Methodology: https://510kreport.com/methodology