510(k) Report

FDA applicant

Wiltec Industries, Ltd.

Greenwood Village, CO2 decisions1996–20090 recalls

FDA records 2 decisions for Wiltec Industries, Ltd. (Greenwood Village, CO) from 1996 to 2009: 2 510(k) clearances. Most are in product codes KKO (Ring, Teething, Fluid-Filled) and FLL (Continuous Measurement Thermometer). 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 Wiltec Industries, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Wiltec Industries, Ltd.’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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