# K112407: Smith Medical Peel-Away Sheath Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical MD, Inc.
- Decided: Feb 9, 2012 after 171 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: 1 generation back to K871132 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073100: Introducer Sets, Models Adelante and Adelante-S, Oscor, Inc. (2007). Our OCR of the scanned summary read K073110, FDA’s number for Merits E600 Series Stair Lift (Merits Health Products Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Adelante® Introducer Set Models: Adelante® and Adelante® S-Lite”.
- K871132: Pharmacia Deltec Subclavian Introducers, Deltec Systems, Inc. (1987) Summary page 2.

## Indications for use
The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the subclavian vein.

Source page: https://510kreport.com/device/K112407
Methodology: https://510kreport.com/methodology