# K013621: BD Saf-T PRN Luer Activated Valve, Model 385100

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Apr 16, 2002 after 162 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970855 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970855: Clave Connector, Icu Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K142527: Extension Set with BD Q-Syte Luer Access Split Septum (2014), 1 descendant of its own
- K202672: Precision Delivery Infusion Set (2021), 0 descendants of its own

## Recalls of this device
- Feb 19, 2015 · Class II · Z-1317-2015: Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
- Nov 6, 2009 · Not classified · Z-1075-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Nov 6, 2009 · Not classified · Z-1073-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Nov 6, 2009 · Not classified · Z-1074-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0751-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0754-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0755-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0753-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0756-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0752-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0750-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

## Indications for use
An intravascular administration set is a device used to administer fluids from a container to a patient’s vascular system through a needle or catheter. An administration set may include the needle or catheter, tubing, flow regulator, drip chamber, infusion line filter, 1V set stopcock, fluid delivery tubing, connectors between parts of the set, side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an IV~ bag or other infusion fluid container. The BD Saf-T PRN Luer Activated Valve needleless connector is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.

Source page: https://510kreport.com/device/K013621
Methodology: https://510kreport.com/methodology