510(k) Report

FDA applicant

Rx Devices, LLC

Landrum, SC1 decision2012–20120 recalls

FDA records 1 decision for Rx Devices, LLC (Landrum, SC) in 2012: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 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 Rx Devices, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Rx Devices, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rx Devices, LLC’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?

  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K112073Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless Access Device 'Y'…Rx Devices, LLC · 2012

The one decision as Rx Devices, LLC →