510(k) Report

FDA applicant

Loving Smarter, Inc.

Winton, NC1 decision1996–19960 recalls

FDA records 1 decision for Loving Smarter, Inc. (Winton, NC) in 1996: 1 510(k) clearance. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Loving Smarter, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Loving Smarter, 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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