# K261041: ClearSafe Closed System

- Pathway: 510(k) (Traditional)
- Applicant: MedSource Labs, LLC
- Decided: Jul 10, 2026 after 101 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: 9 generations back to K942988 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243403: BD Nexiva™ Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2025) Summary page 5.

## Indications for use
The ClearSafe Closed System is indicated to be inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 325 psi with a Luer lock connection only

Source page: https://510kreport.com/device/K261041
Methodology: https://510kreport.com/methodology