510(k) Report

FDA applicant

Perl-Rad Sleep Disorder Lab

Carmel, CA1 decision1999–19990 recalls

FDA records 1 decision for Perl-Rad Sleep Disorder Lab (Carmel, CA) in 1999: 1 510(k) clearance. All are in product code LRK (Device, Anti-Snoring). 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, dental panel, where it files most

How often FDA has decided Perl-Rad Sleep Disorder Lab’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Perl-Rad Sleep Disorder Lab since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Perl-Rad Sleep Disorder Lab by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Perl-Rad Sleep Disorder Lab’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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Which product codes does it file in?

  • LRKDevice, Anti-Snoring1decision

What has FDA decided for it lately?

  • K991209Oral Sleep Disorder AidPerl-Rad Sleep Disorder Lab · 1999

The one decision as Perl-Rad Sleep Disorder Lab →