510(k) Report

FDA applicant

Nano4imaging GmbH

Aachen, DE3 decisions2016–20260 recalls

FDA records 3 decisions for Nano4imaging GmbH (Aachen, DE) from 2016 to 2026: 3 510(k) clearances. All are in product code DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 158 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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, cardiovascular panel, where it files most

How often FDA has decided Nano4imaging GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 12026 (partial year): 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Nano4imaging GmbH by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQXWire, Guide, Catheter3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 158 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 145 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 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.

  • K160594MRWire Guide WireNano4imaging GmbH · 20161cites it
  • K173423MR Wire Guide Wire Straight, MR Wire Guide Wire AngledNano4imaging GmbH · 20171cites it

What has FDA decided for it lately?

  • K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH · 2026
  • K173423MR Wire Guide Wire Straight, MR Wire Guide Wire AngledNano4imaging GmbH · 2017
  • K160594MRWire Guide WireNano4imaging GmbH · 2016

All 3 as Nano4imaging GmbH →