# K250690: Penumbra System (Thunderbolt Aspiration Tubing)

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Jun 10, 2026 after 460 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K003410 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182522: Penumbra System (Modified 110 Aspiration Tubing), Penumbra, Inc. (2018) Summary page 5.

## Recalls of this device
- Jul 24, 2026 · Class II · Z-3331-2026: Due to manufacturing issues reperfusion catheters may fracture.

## Indications for use
Penumbra Reperfusion Catheters and Separators As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Penumbra Thunderbolt Aspiration Tubing As part of the Penumbra System, the Penumbra Thunderbolt Aspiration Tubing is indicated to connect the Penumbra Reperfusion 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/K250690
Methodology: https://510kreport.com/methodology