Atlas FDA

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

NYI — Predicate Candidate Screening

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

246 daysmedian FDA review time
603 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210973MammaPrint FFPE NGS KitAgendia, Inc.2022-09-085260
K201902MammaPrintAgendia, Inc.2020-11-051200
K141142MAMMAPRINT FFPEAgendia2015-01-232660
K141771PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring Technologies, Inc.2014-11-071290
K130010PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAYNanostring Technologies2013-09-062460
K101454MAMMAPRINTAgendia2011-01-282480
K081092MODIFICATION TO MAMMAPRINTAgendia2009-12-116031
K080252MODIFICATION TO MAMMAPRINTAgendia BV2008-07-211721
K070675MAMMAPRINTAgendia BV2007-06-221021
DEN070009MAMMAPRINTAgendia BV2007-02-0670

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