ClearSafe Closed System— 510(k) K261041

Name: FDA 510(k) clearance K261041
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Substantially Equivalent

MedSource Labs, LLC

FDA 510(k) clearance K261041 for ClearSafe Closed System, Substantially Equivalent on 2026-07-10. Applicant: MedSource Labs, LLC. Device class: 2.

Summary

MedSource Labs' ClearSafe Closed System is filed under FOZ, short-term (less than 30 days) therapeutic intravascular catheters. The record doesn't list the system's components or sizes.

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

MedSource Labs filed from Chanhassen, Minnesota. Review took 101 calendar days (March 31 to July 10, 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: 2026-03-31
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chanhassen, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOZ

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K260432 — Ruby Intravascular Catheter2026-09-02
K260165 — Unimpregnated Central Venous Catheter2026-08-10
K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
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.