510(k) Report

FDA applicant

Stellar Medical, LLC

Hudson, FL2 decisions1998–20090 recalls

FDA records 2 decisions for Stellar Medical, LLC (Hudson, FL) from 1998 to 2009: 2 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IPF (Stimulator, Muscle, Powered). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Stellar Medical Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stellar Medical, 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?

  • IYEAccelerator, Linear, Medical1decision
  • IPFStimulator, Muscle, Powered1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K973223Stellar Model HS-04Stellar Medical Corp. · 19981cites it

What has FDA decided for it lately?

  • K092041Stellar Fiducial Marker, Model GfmiaStellar Medical, LLC · 2009
  • K973223Stellar Model HS-04Stellar Medical Corp. · 1998

The one decision as Stellar Medical, LLC →The one decision as Stellar Medical Corp. →

Other applicant names beginning “Stellar”

FDA records each applicant name separately; these may or may not be the same firm.

Stellar Bio Systems, Inc. 7Stellar Contact Lens, Inc. 1Stellar Labs, Inc. 1Stellar Lasers 1