510(k) Report

FDA applicant

Sun Medical, Inc.

Arlington, TX6 decisions1985–20150 recalls

FDA records 6 decisions for Sun Medical, Inc. (Arlington, TX) from 1985 to 2015: 6 510(k) clearances. Most are in product codes EBI (Resin, Denture, Relining, Repairing, Rebasing) and FYD (Apparatus, Exhaust, Surgical). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sun Medical Co., Ltd.”.

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 Sun Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sun Medical, 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?

  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions
  • FYDApparatus, Exhaust, Surgical1decision
  • HIFInsufflator, Laparoscopic1decision
  • GEXPowered Laser Surgical Instrument1decision
  • HDYDilator, Cervical, Hygroscopic-Laminaria1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K911154Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200Sun Medical, Inc. · 19912cite it

What has FDA decided for it lately?

  • K150511Coating MaterialSun Medical Co., Ltd. · 2015
  • K143265Acrylic BlockSun Medical Co., Ltd. · 2015
  • K921963Disposable, Filtered Insufflation Tubing, 92-900Sun Medical, Inc. · 1992
  • K911154Sun Medical Smoke/Fluid Evac Syst, Model Sfe-200Sun Medical, Inc. · 1991
  • K874948Sun Medical Smoke Evacuator SystemSun Medical, Inc. · 1988
  • K845006Sun Medical Laminaria Cervical DilatorSun Medical, Inc. · 1985

All 4 as Sun Medical, Inc. →All 2 as Sun Medical Co., Ltd. →