510(k) Report

FDA applicant

Safeop Surgical, Inc.

Hunt Valley, MD2 decisions2014–20190 recalls

FDA records 2 decisions for Safeop Surgical, Inc. (Hunt Valley, MD) from 2014 to 2019: 2 510(k) clearances. All are in product code GWF (Stimulator, Electrical, Evoked Response). Its devices cite 7 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, neurology panel, where it files most

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

FDA decisions per year

1in 2019

2014: 12019: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Safeop Surgical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Safeop Surgical, 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?

  • GWFStimulator, Electrical, Evoked Response2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K182542The EPAD 2 SystemSafeop Surgical, Inc. · 20192cite it
  • K132616EPADSafeop Surgical, Inc. · 20142cite it

What has FDA decided for it lately?

  • K182542The EPAD 2 SystemSafeop Surgical, Inc. · 2019
  • K132616EPADSafeop Surgical, Inc. · 2014

All 2 as Safeop Surgical, Inc. →