510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171954Substantially Equivalent

ClearLine IV

Clearline MD, Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171954 is the FDA 510(k) clearance record for ClearLine IV, a class II device, cleared for Clearline MD on under FDA product code OKL (Intravascular Administration Set, Automated Air Removal System). FDA's definition for product code OKL reads: "An intravascular administration set, automated air removal system is a prescription device used to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the IV fluid". FDA records list one 510(k) clearance for Clearline MD. As of , FDA records show no recalls naming K171954.

Clearance record

Decision date
Received
(210 days to decision)
Product code
OKL Intravascular Administration Set, Automated Air Removal System
Regulation
21 CFR 880.5445
Device class
Class II
Review panel
General Hospital
Applicant
Clearline MD 300 Tradecenter, Suite 5400, Woburn MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OKL

Trailing 12 months

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

FDA records show no clearances under product code OKL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OKL, 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