# K131555: Medsource IV Safety Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medsource International, LLC
- Decided: Jan 31, 2014 after 247 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
Longest line of descent: 1 generation back to K984059 (1999). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984059: Angiocath Autoguard Catheter, Insyte Autoguard Catheter, Bd Becton Dickinson Vacutainer Systems Preanalytic (1999) Summary page 2.

## Most influential descendants
- K161779: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter (2016), 1 descendant of its own
- K223788: The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (2023), 0 descendants of its own
- K193278: MedSource CathMED IV Catheter (2020), 0 descendants of its own
- K150611: MedSource ClearSafe Safety IV Catheter (2015), 0 descendants of its own

## Indications for use
The MedSource IV Safety Catheter is indicated to sample blood, or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.

Source page: https://510kreport.com/device/K131555
Methodology: https://510kreport.com/methodology