510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190043Unknown

SafeBreak Vascular

Site Saver, Inc. D/B/A Lineus Medical, Fayetteville AR / Direct, Unknown
FDA source (opens on fda.gov)

DEN190043 is the FDA 510(k) clearance record for SafeBreak Vascular, a class II device, cleared for Site Saver, Inc. D/B/A Lineus Medical on under FDA product code QOI (Intravenous Catheter Force-Activated Separation Device.). FDA's definition for product code QOI reads: "An intravenous (IV) catheter force-activated separation device. An intravenous catheter force-activated separation device is placed inline with an intravenous catheter and an intravascular administration set, including any administration...". FDA records list one 510(k) clearance for Site Saver, Inc. D/B/A Lineus Medical. As of , FDA records show no recalls naming DEN190043.

Clearance record

Decision date
Received
(617 days to decision)
Product code
QOI Intravenous Catheter Force-Activated Separation Device.
Regulation
21 CFR 880.5220
Device class
Class II
Review panel
General Hospital
Applicant
Site Saver, Inc. D/B/A Lineus Medical 179 N. Church Ave., Suite 202, Fayetteville AR
Third party review
No

Clearances, product code QOI

Trailing 12 months

FDA records hold no clearances under product code QOI in the trailing twelve months.

FDA records show no clearances under product code QOI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QOI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260