510(k) Report

FDA applicant

Salumedica, LLC

Atlanta, GA2 decisions2000–20100 recalls

FDA records 2 decisions for Salumedica, LLC (Atlanta, GA) from 2000 to 2010: 2 510(k) clearances. All are in product code JXI (Cuff, Nerve). Its devices cite 3 predicates, 1 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, neurology panel, where it files most

How often FDA has decided Salumedica, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Salumedica, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JXICuff, Nerve2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K002098Salumedica Nerve CuffSalumedica, LLC · 20005cite it

What has FDA decided for it lately?

  • K100382Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331Salumedica, LLC · 2010
  • K002098Salumedica Nerve CuffSalumedica, LLC · 2000

All 2 as Salumedica, LLC →