510(k) Report

FDA applicant

Biomedevice, Ltd.

Laguna Hills, CA1 decision2007–20070 recalls

FDA records 1 decision for Biomedevice, Ltd. (Laguna Hills, CA) in 2007: 1 510(k) clearance. All are in product code KKO (Ring, Teething, Fluid-Filled). Its devices cite 3 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, dental panel, where it files most

How often FDA has decided Biomedevice, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biomedevice, Ltd.’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

Which product codes does it file in?

  • KKORing, Teething, Fluid-Filled1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K072082Gumease Dental MouthpieceBiomedevice, Ltd. · 2007

The one decision as Biomedevice, Ltd. →