510(k) Report

FDA applicant

Sunmed, Inc.

Redding, CA7 decisions1993–20240 recalls

FDA records 7 decisions for Sunmed, Inc. (Redding, CA) from 1993 to 2024: 7 510(k) clearances. Most are in product codes LZN (Cement Obturator) and BXN (Stimulator, Nerve, Battery-Powered). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sunmed, LLC”, “Sunmed”.

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

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

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

FDA decisions per year

1in 2024

2007: 12008: 12013: 12024: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sunmed, Inc.’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?

  • LZNCement Obturator2decisions
  • BXNStimulator, Nerve, Battery-Powered1decision
  • CCWLaryngoscope, Rigid1decision
  • BSKCuff, Tracheal Tube, Inflatable1decision
  • EZLCatheter, Retention Type, Balloon1decision
  • IPFStimulator, Muscle, Powered1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K081805CuffalertSunmed · 20083cite it
  • K955632Orthoplug Soft Bone DesignSunmed, Inc. · 19961cites it
  • K121743Easymed Peripheral Nerve Stimulator-SunstinSunmed, LLC · 20131cites it
  • K955631Orthoplug Hard Bone DesignSunmed, Inc. · 19961cites it

What has FDA decided for it lately?

  • K233098MYOTouch Muscle StimulatorSunmed, LLC · 2024
  • K121743Easymed Peripheral Nerve Stimulator-SunstinSunmed, LLC · 2013
  • K081805CuffalertSunmed · 2008
  • K062112Sunmed Foley CathetersSunmed, Inc. · 2007
  • K955632Orthoplug Soft Bone DesignSunmed, Inc. · 1996
  • K955631Orthoplug Hard Bone DesignSunmed, Inc. · 1996
  • K921263Sunlite LaryngoscopeSunmed, Inc. · 1993

All 4 as Sunmed, Inc. →All 2 as Sunmed, LLC →The one decision as Sunmed →