510(k) Report

FDA applicant

Sicat GmbH & Co. KG

Bonn, DE9 decisions2006–20191 recall

FDA records 9 decisions for Sicat GmbH & Co. KG (Bonn, DE) from 2006 to 2019: 9 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MQC (Mouthguard, Prescription). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 6 of them its own earlier devices. 1 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 Sicat GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2009: 22011: 12014: 12015: 12016: 12018: 12019: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sicat GmbH & Co. KG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sicat GmbH & Co. KG’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?

  • LLZSystem, Image Processing, Radiological7decisions
  • MQCMouthguard, Prescription1decision
  • LRKDevice, Anti-Snoring1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 97 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 107 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 6 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.

  • K103723Sicat Implant V1.2Sicat GmbH & Co. KG · 20113cite it
  • K133320Sicat FunctionSicat GmbH & Co. KG · 20142cite it
  • K061472Galileos Implant, V 1.0Sicat GmbH & Co. KG · 20062cite it
  • K153291Sicat OptisleepSicat GmbH & Co. KG · 20162cite it
  • K090119Sicat ImplantSicat GmbH & Co. KG · 20092cite it

What has FDA decided for it lately?

  • K192348SICAT Implant V2.0Sicat GmbH & Co. KG · 20191 recall
  • K180262SICAT EndoSicat GmbH & Co. KG · 2018
  • K153291Sicat OptisleepSicat GmbH & Co. KG · 2016
  • K143655Sicat OptimotionSicat GmbH & Co. KG · 2015
  • K133320Sicat FunctionSicat GmbH & Co. KG · 2014
  • K103723Sicat Implant V1.2Sicat GmbH & Co. KG · 2011
  • K093090Galileos Implant, Version 1.7Sicat GmbH & Co. KG · 2009
  • K090119Sicat ImplantSicat GmbH & Co. KG · 2009

All 9 as Sicat GmbH & Co. KG →

What has been recalled?

1 recall linked to its devices; the latest:

  • K192348Sicat Implant V2.0Jul 15, 2020Class II