# K101422: The Power Wand Safety Introducer with an Extended Dwell Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Access Scientific, Inc.
- Decided: Mar 22, 2011 after 306 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 K932323 (1993). 15 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081697: The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006, Access Scientific, Inc. (2008) Summary page 1.
- K093022: The Picc Wand Peelable Safety Introducer, Access Scientific, Inc. (2010) Summary page 1.
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 2.
- K042862: BD Onecath, Becton Dickinson Infusion Therapy Systems, Inc. (2004)

## Most influential descendants
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own
- K133856: Powerglide Midline Catheter (2014), 12 descendants of its own
- K153280: PowerGlide Pro Midline Catheter (2016), 5 descendants of its own
- K150407: BioFlo Midline Catheter (2015), 5 descendants of its own
- K162377: PowerGlide Pro Midline Catheter (2016), 4 descendants of its own

## Indications for use
The Power WAND Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.

Source page: https://510kreport.com/device/K101422
Methodology: https://510kreport.com/methodology