510(k) Report

FDA applicant

Health Line International Corporation (Hlic)

Clearfield, UT2 decisions2007–20120 recalls

FDA records 2 decisions for Health Line International Corporation (Hlic) (Clearfield, UT) from 2007 to 2012: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Health Line International Corporation (Hlic)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Health Line International Corporation (Hlic) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 20121cites it

What has FDA decided for it lately?

  • K113622Orion II CT CVCHealth Line International Corporation (Hlic) · 2012
  • K070630Health Line International Corporation's Primary IV Solution Administration Set with Check ValveHealth Line International Corporation (Hlic) · 2007

All 2 as Health Line International Corporation (Hlic) →