# K220981: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe

- Pathway: 510(k) (Traditional)
- Applicant: Fehling Surgical Instruments, Inc.
- Decided: Apr 20, 2023 after 381 days
- Product code: DWP (Dilator, Vessel, Surgical)
- Device class: 2
- Regulation: 21 CFR 870.4475
- 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 K030788 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183438: Geomed Vascular Dilators, Geomed Medizin-Technik GmbH & Co. (2019) Summary page 4.

## Indications for use
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Source page: https://510kreport.com/device/K220981
Methodology: https://510kreport.com/methodology