# K222786: 072 Aspiration System

- Pathway: 510(k) (Traditional)
- Applicant: Q'Apel Medical, Inc.
- Decided: Aug 25, 2023 after 344 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003410 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
4 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191946: Penumbra System Penumbra JET 7X, Penumbra, Inc. (2020) Summary page 4.

## Recalls of this device
- Feb 26, 2025 · Class I · Z-1512-2025: Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

## Indications for use
072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is 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 - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment. Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.

Source page: https://510kreport.com/device/K222786
Methodology: https://510kreport.com/methodology