510(k) Report

FDA applicant

Emt-Rx

Raleigh, NC1 decision2002–20022 recalls

FDA records 1 decision for Emt-Rx (Raleigh, NC) in 2002: 1 510(k) clearance. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). 2 recalls are 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 Emt-Rx’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emt-Rx since 2007.

Recalls per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Emt-Rx by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K002142Saline IV Flush SyringeEmt-Rx · 20021cites it

What has FDA decided for it lately?

  • K002142Saline IV Flush SyringeEmt-Rx · 20022 recalls

The one decision as Emt-Rx →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K002142Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per cartonJul 30, 2007
  • K002142Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.Jul 30, 2007