510(k) Report

FDA applicant

Apteryx, Inc.

Akron, OH3 decisions1998–20180 recalls

FDA records 3 decisions for Apteryx, Inc. (Akron, OH) from 1998 to 2018: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 1 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 Apteryx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Apteryx, 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?

  • LLZSystem, Image Processing, Radiological3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K132342XVWEBApteryx, Inc. · 20132cite it
  • K983111Xray VisionApteryx, Inc. · 19981cites it

What has FDA decided for it lately?

  • K182815XVWeb 3DApteryx, Inc. · 2018
  • K132342XVWEBApteryx, Inc. · 2013
  • K983111Xray VisionApteryx, Inc. · 1998

All 3 as Apteryx, Inc. →