510(k) Report

FDA applicant

Lineus Medical

Fayetteville, AZ3 decisions2022–20230 recalls

FDA records 3 decisions for Lineus Medical (Fayetteville, AZ) from 2022 to 2023: 3 510(k) clearances. All are in product code QOI (Intravenous Catheter Force-Activated…). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Lineus Medical, LLC”.

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 Lineus Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2022: 12023: 2
2022high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Lineus Medical by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lineus Medical’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?

  • QOIIntravenous Catheter Force-Activated Separation Device.3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222791SafeBreak VascularLineus Medical, LLC · 20221cites it
  • K223486SafeBreak® VascularLineus Medical · 20231cites it

What has FDA decided for it lately?

  • K231957SafeBreak® VascularLineus Medical · 2023
  • K223486SafeBreak® VascularLineus Medical · 2023
  • K222791SafeBreak VascularLineus Medical, LLC · 2022

All 2 as Lineus Medical →The one decision as Lineus Medical, LLC →