510(k) Report

FDA applicant

Site Saver, Inc. D/B/A Lineus Medical

Fayetteville, AR1 decision2021–20210 recalls

FDA records 1 decision for Site Saver, Inc. D/B/A Lineus Medical (Fayetteville, AR) in 2021: 1 De Novo grant. All are in product code QOI (Intravenous Catheter Force-Activated…). 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 Site Saver, Inc. D/B/A Lineus Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Site Saver, Inc. D/B/A Lineus Medical by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QOIIntravenous Catheter Force-Activated Separation Device.1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • DEN190043SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical · 20212cite it

What has FDA decided for it lately?

  • DEN190043SafeBreak VascularSite Saver, Inc. D/B/A Lineus Medical · 2021

The one decision as Site Saver, Inc. D/B/A Lineus Medical →

Other applicant names beginning “Site”

FDA records each applicant name separately; these may or may not be the same firm.

Site Microsurgical Systems, Inc. 30