Atlas FDA

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

PEN · Predicate Candidate Screening

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

90 daysmedian FDA review time
203 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation2025-04-182030
K243759BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ABiofire Diagnostics, LLC2024-12-20140
K213236ePlex Blood Culture Identification Gram Negative (BCID-GN) PGenmark Diagnostics, Incorporated2022-04-272090
K193519BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC2020-03-18904
K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.2019-06-281340
K182619ePlex Blood Culture Identification Gram Negative (BCID-GN) PGenmark Diagnostics, Incorporated2019-04-122000
K181493FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC2018-07-05291
K160457FilmArray Blood Culture Identification (BCID) panel for use Biofire Diagnostics, LLC2016-03-15252
K143171FilmArray Blood Culture Identification (BCID) Panel for use Biofire Diagnostics, LLC2015-01-30872
K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GNanosphere, Inc.2014-01-081205
K130914FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANELBiofire Diagnostics, Inc.2013-06-21803

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