# K261242: SimplGuide

- Pathway: 510(k) (Traditional)
- Applicant: Pendracare
- Decided: Jun 25, 2026 after 71 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924607 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193125: R2P Destination Slender Guiding Sheath, Terumo Medical Corporation (2020) Summary page 5.

## Indications for use
The SimplGuide guiding sheath is indicated for the introduction of therapeutic and diagnostic devices into the peripheral and coronary vasculature through an access site.

Source page: https://510kreport.com/device/K261242
Methodology: https://510kreport.com/methodology