Atlas FDA

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

Orsonique, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time
35 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972373OVATION HDPOrsonique, Inc.1997-07-29340
K963822OVATION AGC-3Orsonique, Inc.1996-10-28350
K963821OVATION AGC-1Orsonique, Inc.1996-10-28350
K963820OVATION LINEAROrsonique, Inc.1996-10-28350
K963819OVATION ASPOrsonique, Inc.1996-10-28350
K963818OVATION AGC-2Orsonique, Inc.1996-10-28350

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