Atlas FDA

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

PAM · Predicate Candidate Screening

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

206 daysmedian FDA review time
249 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbH2026-08-062260
K243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex Corporation2025-06-062060
K181663ePlex Blood Culture Identification Panel - Gram Positive (BCGenmark Diagnostics, Incorporated2018-12-201780
K163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc.2017-08-082490
K152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, Inc.2016-03-252071
K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TENanosphere, Inc.2012-09-19336
DEN120014VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GNanosphere, Inc.2012-06-26110

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