510(k) Report

FDA applicant

Medtec, Inc. D/B/A Civco Medical Solutions

Orange City, IA1 decision2016–20160 recalls

FDA records 1 decision for Medtec, Inc. D/B/A Civco Medical Solutions (Orange City, IA) in 2016: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 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, radiology panel, where it files most

How often FDA has decided Medtec, Inc. D/B/A Civco Medical Solutions’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Medtec, Inc. D/B/A Civco Medical Solutions by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtec, Inc. D/B/A Civco Medical…’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?

  • IYEAccelerator, Linear, Medical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for…Medtec, Inc. D/B/A Civco Medical Solutions · 20162cite it

What has FDA decided for it lately?

  • K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for…Medtec, Inc. D/B/A Civco Medical Solutions · 2016

The one decision as Medtec, Inc. D/B/A Civco Medical Solutions →

Other applicant names beginning “Medtec”

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

Medtec, Inc. 41Medtec Inc. Dba Civco Medical Solutions 2Medtec, Inc. Dba Civco Medical Solutions and Civco 1Medtec Inc Dba Civco Medical Solutions and Civco… 1