FDA applicant

Kappler USA

Guntersville, AL2 decisions1996–20000 recalls

FDA records 2 decisions for Kappler USA (Guntersville, AL) from 1996 to 2000: 2 510(k) clearances. All are in product code FYA (Gown, Surgical). Its devices cite 2 predicates, 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 Kappler USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kappler USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kappler USA’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Kappler”

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

Kappler, Inc. 2

Kappler USA

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Kappler”