510(k) Report

FDA applicant

Kappler, Inc.

Guntersville, AL2 decisions1994–19940 recalls

FDA records 2 decisions for Kappler, Inc. (Guntersville, AL) in 1994: 2 510(k) clearances. Most are in product codes FXP (Cover, Shoe, Operating-Room) and FYA (Gown, Surgical). 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 Kappler, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kappler, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kappler, 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?

  • FXPCover, Shoe, Operating-Room1decision
  • FYAGown, Surgical1decision

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.

  • K932694Kappler Pro/Vent Procedure GownKappler, Inc. · 19941cites it

What has FDA decided for it lately?

  • K932738Kappler Pro/Vent BootKappler, Inc. · 1994
  • K932694Kappler Pro/Vent Procedure GownKappler, Inc. · 1994

All 2 as Kappler, Inc. →

Other applicant names beginning “Kappler”

FDA records each applicant name separately; these may or may not be the same firm.

Kappler USA 2