510(k) Report

FDA applicant

Sometech Corporation

Norcross, GA4 decisions2003–20130 recalls

FDA records 4 decisions for Sometech Corporation (Norcross, GA) from 2003 to 2013: 4 510(k) clearances. Most are in product codes HEX (Colposcope (And Colpomicroscope)) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sometech Incorporated”.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sometech Corporation’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?

  • HEXColposcope (And Colpomicroscope)1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision
  • ILYLamp, Infrared, Therapeutic Heating1decision

Whose devices does it build on?

Its devices cite 6 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.

  • K051956DR. Oppel ST-501Sometech Incorporated · 20051cites it

What has FDA decided for it lately?

  • K121401Tender TouchSometech Corporation · 2013
  • K051956DR. Oppel ST-501Sometech Incorporated · 2005
  • K024186X-VIEWSometech Corporation · 2004
  • K031436MediscopeSometech Corporation · 2003

All 3 as Sometech Corporation →The one decision as Sometech Incorporated →