FDA applicant

Lafayette Pharmacal, Inc.

Lafayette, IN4 decisions1986–19930 recalls

FDA records 4 decisions for Lafayette Pharmacal, Inc. (Lafayette, IN) from 1986 to 1993: 4 510(k) clearances. Most are in product codes KGC (Tube, Gastro-Enterostomy) and FCE (Enema Kit). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Lafayette Pharmacal, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lafayette Pharmacal, Inc.’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 “Lafayette”

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

Lafayette Pharmaceuticals, Inc. 1

Lafayette Pharmacal, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Lafayette”