510(k) Report

FDA applicant

Kolster Methods

Fullerton, CA3 decisions1989–19940 recalls

FDA records 3 decisions for Kolster Methods (Fullerton, CA) from 1989 to 1994: 3 510(k) clearances. Most are in product codes GEA (Cannula, Surgical, General & Plastic Surgery) and HGH (Cannula, Suction, Uterine). 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 Kolster Methods’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kolster Methods since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kolster Methods’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?

  • GEACannula, Surgical, General & Plastic Surgery1decision
  • HGHCannula, Suction, Uterine1decision
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K895761General AsperatorKolster Methods · 19892cite it

What has FDA decided for it lately?

  • K935820Kolster MethodsKolster Methods · 1994
  • K895762Canula Suction for Surgical General and PlasticKolster Methods · 1989
  • K895761General AsperatorKolster Methods · 1989

All 3 as Kolster Methods →