510(k) Report

FDA applicant

Kub Technologies, Inc.

Stratford, CT10 decisions2007–20210 recalls

FDA records 10 decisions for Kub Technologies, Inc. (Stratford, CT) from 2007 to 2021: 10 510(k) clearances. Most are in product codes MWP (Cabinet, X-Ray System) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 164 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 7 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 Kub Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2021

2007: 12009: 12011: 12014: 12015: 12019: 12020: 12021: 3
2007high 3 (2021) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kub Technologies, Inc.’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?

  • MWPCabinet, X-Ray System6decisions
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions
  • IZLSystem, X-Ray, Mobile1decision
  • KPRSystem, X-Ray, Stationary1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 164 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 154 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 7 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.

  • K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 20075cite it
  • K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc. · 20192cite it
  • K083510Kubtec Xpert 20Kub Technologies, Inc. · 20091cites it
  • K200756Kubtec Mozart SupraKub Technologies, Inc. · 20201cites it

What has FDA decided for it lately?

  • K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021
  • K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc. · 2021
  • K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc. · 2021
  • K200756Kubtec Mozart SupraKub Technologies, Inc. · 2020
  • K183624Kubtec Mozart (Xpert42)Kub Technologies, Inc. · 2019
  • K151221Kubtec DIGIVIEW 395Kub Technologies, Inc. · 2015
  • K141539Kubtec X250Kub Technologies, Inc. · 2014
  • K103348Digiview 250Kub Technologies, Inc. · 2011

All 10 as Kub Technologies, Inc. →