# K073100: Introducer Sets, Models Adelante and Adelante-S

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Nov 30, 2007 after 28 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K112407: Smith Medical Peel-Away Sheath Introducers (2012), 0 descendants of its own

## Recalls of this device
- Aug 1, 2011 · Not classified · Z-0055-2012: The product may contain an incorrect size catheter and introducer.
- Jul 3, 2008 · Not classified · Z-0130-2009: Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F.

Source page: https://510kreport.com/device/K073100
Methodology: https://510kreport.com/methodology