510(k) Report

FDA applicant

Remicalm, LLC

Houston, TX2 decisions2008–20090 recalls

FDA records 2 decisions for Remicalm, LLC (Houston, TX) from 2008 to 2009: 2 510(k) clearances. All are in product code NXV (Diagnostic Light, Soft Tissue Detector). Its devices cite 4 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, dental panel, where it files most

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

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Remicalm, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NXVDiagnostic Light, Soft Tissue Detector2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K090135Trimira Identafi 3000Remicalm, LLC · 20092cite it
  • K082603Trimira Ocs 3000Remicalm, LLC · 20081cites it

What has FDA decided for it lately?

  • K090135Trimira Identafi 3000Remicalm, LLC · 2009
  • K082603Trimira Ocs 3000Remicalm, LLC · 2008

All 2 as Remicalm, LLC →