Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

OEM · Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

53 daysmedian FDA review time
227 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230349Lyra RSV+hMPV AssayQuidel Corporation2023-03-10290
K132200PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.2013-08-14290
K122189QUIDEL MOLECULAR RSV + HMPV ASSAYQuidel Corp.2013-03-082270
K123838PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.2013-01-16340
K112490QUIDEL MOLECULAR HMPV ASSAYQuidel Corp.2011-12-151080
K082688PRO HMPV+ ASSAYProdesse, Inc.2008-11-07530

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