# K112887: Upstream Needle Holder, Upstream Needle Holder with Shut-Off Connector

- Pathway: 510(k) (Traditional)
- Applicant: Upstream Peripheral Technologies
- Decided: Mar 21, 2012 after 173 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 K013304 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013304: BD Introsyte Precision Introducer, BD Introsyte Autogaurd Shielded Introducer, Becton Dickinson Infusion Therapy Systems, Inc. (2002) Summary page 1.

## Indications for use
The Upstream Needle Holders are intended to facilitate the placement of guidewires into the vascular system.

Source page: https://510kreport.com/device/K112887
Methodology: https://510kreport.com/methodology