# K092623: F.a.S.T. System Sed and CXD

- Pathway: 510(k) (Special)
- Applicant: Genesis Medical Interventional, Inc.
- Decided: Oct 30, 2009 after 65 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: 3 generations back to K832023 (1983). 15 ancestors in all.
7 later devices descend from it; 1 cites it directly.
3 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040010: Genesis Medical Interventional F.a.S.T. (Facilitated Aspiration/Suction Thrombectomy) Systems, Genesis Medical Interventional, Inc. (2004) Summary page 5.

## Most influential descendants
- K132281: ReVive PV (Peripheral Vasculature) Thrombectomy Device (2013), 6 descendants of its own
- K221204: Excipio SV Thrombectomy Device (2022), 2 descendants of its own
- K201085: NeVa PV Thrombectomy Device (2021), 2 descendants of its own
- K223897: Excipio LV Thrombectomy Device (2023), 1 descendant of its own
- K254211: pVasc Net Mechanical Thrombectomy Device (2026), 0 descendants of its own

## Indications for use
The F.A.S.T.TM System SED and CXD are indicated for: The non-surgical removal of emboli and thrombi from blood vessels. The non-surgical removal of thrombi from synthetic grafts. Temporary use in vessel/graft occlusions. Injection, infusion, and/or aspiration. of contrast media and other fluids into or from a vessel/graft. Catheter placement over a guidewire.

Source page: https://510kreport.com/device/K092623
Methodology: https://510kreport.com/methodology