510(k) Report

FDA applicant

North American Rescue Products, Inc.

Greer, SC1 decision2013–20131 recall

FDA records 1 decision for North American Rescue Products, Inc. (Greer, SC) in 2013: 1 510(k) clearance. All are in product code DXC (Clamp, Vascular). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, cardiovascular panel, where it files most

How often FDA has decided North American Rescue Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2013high 1 (2025) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — North American Rescue Products, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXCClamp, Vascular1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K123194Junctional Emergency Treatment Tool Model 30-0088North American Rescue Products, Inc. · 20131 recall

The one decision as North American Rescue Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123194JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT…Jul 1, 2025Class II