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.

Clearance details

Applicant: MedSource Labs, LLC
Product code: 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

view all

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
K252513 — Polywin Safety (14G x 51mm +17 more2026-04-01

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.