510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231957Substantially Equivalent

SafeBreak® Vascular

Lineus Medical, Fayetteville AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231957 is the FDA 510(k) clearance record for SafeBreak® Vascular, a class II device, cleared for 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 3 510(k) clearances for Lineus Medical, from to . As of , FDA records show no recalls naming K231957.

Clearance record

Decision date
Received
(88 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
Lineus Medical 179 N. Church Ave., Suite 202, Fayetteville AZ
510(k) summary
Summary PDF
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