MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter— 510(k) K260539

Name: FDA 510(k) clearance K260539
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Substantially Equivalent

MedSource Labs, LLC

FDA 510(k) clearance K260539 for MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter, Substantially Equivalent on 2026-07-09. Applicant: MedSource Labs, LLC. Device class: 2.

Summary

MedSource Labs' clearance covers the MedSource QuickSafe and PurSafe Safety IV Catheters, filed under FOZ, short-term (less than 30 days) therapeutic intravascular catheters. The record doesn't give gauges or say how the two differ.

Class II, 21 CFR 880.5200. General Hospital is both the classification panel and the review panel, and it came in as a Traditional 510(k).

MedSource Labs filed from Chanhassen, Minnesota. Review took 142 calendar days (February 17 to July 9, 2026).

Clearance details

Applicant: MedSource Labs, LLC
Product code: Product code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2026-02-17
Decision date: 2026-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

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K261041 — ClearSafe Closed System2026-07-10
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15
K252137 — BD Insyte IV Catheter2026-04-02

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.