510(k) Report

FDA applicant

Controlrad, Inc.

Norcross, GA6 decisions2019–20210 recalls

FDA records 6 decisions for Controlrad, Inc. (Norcross, GA) from 2019 to 2021: 6 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and KKX (Drape, Surgical, Antimicrobial). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 6 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 Controlrad, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2019: 12020: 32021: 2
2019high 3 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Controlrad, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Controlrad, 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?

  • OWBInterventional Fluoroscopic X-Ray System5decisions
  • KKXDrape, Surgical, Antimicrobial1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 60 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 6 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200663ControlRad Trace Model 9Controlrad, Inc. · 20202cite it
  • K202431ControlRad Select Model ZControlrad, Inc. · 20202cite it
  • K183109ControlRad Trace Model 8Controlrad, Inc. · 20192cite it

What has FDA decided for it lately?

  • K213455ControlRad Select Model ZControlrad, Inc. · 2021
  • K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9Controlrad, Inc. · 2021
  • K202431ControlRad Select Model ZControlrad, Inc. · 2020
  • K200663ControlRad Trace Model 9Controlrad, Inc. · 2020
  • K200238ControlRad Sterile CoverControlrad, Inc. · 2020
  • K183109ControlRad Trace Model 8Controlrad, Inc. · 2019

All 6 as Controlrad, Inc. →