# K161779: MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medsource International, LLC
- Decided: Nov 3, 2016 after 127 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: 2 generations back to K984059 (1999). 2 ancestors in all.
1 later device descends 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)
- K131555: Medsource IV Safety Catheter, Medsource International, LLC (2014) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV 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/K161779
Methodology: https://510kreport.com/methodology