FDA applicant

Radiant Innovation, Inc.

Hsinchu, TW15 decisions2001–20240 recalls

FDA records 15 decisions for Radiant Innovation, Inc. (Hsinchu, TW) from 2001 to 2024: 15 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 166 days from receipt to decision, against 209 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 15 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2024

2007high 3 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Radiant Innovation, 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 “Radiant”

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

Radiant Medical 6 Radiant Express, LLC 1 Radiant Spectacles Manufacturers 1

Radiant Innovation, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Radiant”