510(k) Report

FDA applicant

Aurolab

Madison, WI4 decisions2003–20220 recalls

FDA records 4 decisions for Aurolab (Madison, WI) from 2003 to 2022: 4 510(k) clearances. Most are in product codes LYX (Media, Corneal Storage) and GAR (Suture, Nonabsorbable, Synthetic, Polyamide). Its devices cite 1 predicate, 0 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2022

2014: 12022: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Aurolab’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?

  • LYXMedia, Corneal Storage1decision
  • GARSuture, Nonabsorbable, Synthetic, Polyamide1decision
  • GAPSuture, Nonabsorbable, Silk1decision
  • GAMSuture, Absorbable, Synthetic, Polyglycolic Acid1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K024091Silk SuturesAurolab · 20031cites it

What has FDA decided for it lately?

All 4 as Aurolab →