Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Assure Tech., LLC — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time
88 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Assure Tech., LLC2026-07-17350
K260754Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 AntigAssure Tech., LLC2026-06-05880
K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine TestAssure Tech., LLC2025-08-15250
K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Assure Tech., LLC2025-02-13280
K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssuAssure Tech., LLC2025-02-07430
K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early PregnaAssure Tech., LLC2025-01-15570
K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid FentAssure Tech., LLC2024-03-06300

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda