510(k) Report

FDA applicant

Health Line International Corporation

Salt Lake City, UT12 decisions2006–20260 recalls

FDA records 12 decisions for Health Line International Corporation (Salt Lake City, UT) from 2006 to 2026: 12 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and LJS (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 4 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’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2010: 12012: 12013: 12014: 22016: 12019: 12020: 22023: 12026 (partial year): 1
2007high 2 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Health Line International Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days3decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions
  • FPASet, Administration, Intravascular2decisions
  • DQYCatheter, Percutaneous1decision
  • MSDCatheter, Hemodialysis, Implanted1decision
  • MPBCatheter, Hemodialysis, Non-Implanted1decision

Also: NIE (1), DYB (1).

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 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.

  • K101329Synergy CT PiccHealth Line International Corporation · 20104cite it
  • K160448ArtlineHealth Line International Corporation · 20161cites it
  • K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 20141cites it
  • K130034Uni-PiccHealth Line International Corporation · 20131cites it
  • K060352Health Line International Corporations,S IV Administrative SetsHealth Line International Corporation · 20061cites it
  • K140270Nexus Midline CT CatheterHealth Line International Corporation · 20141cites it

What has FDA decided for it lately?

  • K261950Health Line Tearaway IntroducerHealth Line International Corporation · 2026
  • K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation · 2023
  • K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation · 2020
  • K200263Health Line CT Midline CatheterHealth Line International Corporation · 2020
  • K192533Health Line CT CVCHealth Line International Corporation · 2019
  • K160448ArtlineHealth Line International Corporation · 2016
  • K140270Nexus Midline CT CatheterHealth Line International Corporation · 2014
  • K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation · 2014

All 12 as Health Line International Corporation →