FDA applicant

Barry J. Kaplan, Inc.

San Diego, CA1 decision1998–19980 recalls

FDA records 1 decision for Barry J. Kaplan, Inc. (San Diego, CA) in 1998: 1 510(k) clearance. All are in product code LKY (Device, External Penile Rigidity). 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 Barry J. Kaplan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Barry J. Kaplan, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Barry J. Kaplan, 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

Other applicant names beginning “Barry”

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

Barry S. Smith Co. 1 Barry Markman, M.D. 1

Barry J. Kaplan, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Barry”