# K971339: Insyte, Insyte-W, Insyte Autoguard Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vascular Access, Inc.
- Decided: Dec 24, 1997 after 258 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
63 later devices descend from it; 6 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Vascular Access INSYTE®, INSYTE-W®, and INSYTE® AUTOGUARD™ brand catheters: named in the summary without a submission number

## Most influential descendants
- K020785: Introcan Safety IV Catheter (2002), 55 descendants of its own
- K101422: The Power Wand Safety Introducer with an Extended Dwell Catheter (2011), 25 descendants of its own
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own
- K111236: Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 (2011), 15 descendants of its own
- K133856: Powerglide Midline Catheter (2014), 12 descendants of its own

## Indications for use
As indicated in 21 CFR 870.1200, to sample blood, to monitor blood pressure, or to introduce substances into the heart and vessels. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

Source page: https://510kreport.com/device/K971339
Methodology: https://510kreport.com/methodology