Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Biofire Diagnostics, LLC — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
302 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Biofire Diagnostics, LLC | 2025-08-14 | 272 | 0 |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | 2025-01-16 | 29 | 0 |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-A | Biofire Diagnostics, LLC | 2024-12-20 | 14 | 0 |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024-11-07 | 90 | 0 |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Biofire Diagnostics, LLC | 2024-05-30 | 30 | 0 |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Biofire Diagnostics, LLC | 2024-03-26 | 187 | 1 |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Biofire Diagnostics, LLC | 2023-04-13 | 29 | 0 |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023-03-16 | 29 | 3 |
| K222601 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | 2022-10-27 | 59 | 1 |
| DEN200066 | BioFire Joint Infection (JI) Panel | Biofire Diagnostics, LLC | 2022-04-29 | 549 | 0 |
| K212727 | FilmArray Pneumonia Panel | Biofire Diagnostics, LLC | 2021-09-22 | 26 | 1 |
| DEN200031 | BioFire Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics, LLC | 2021-03-17 | 302 | 0 |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC | 2020-03-18 | 90 | 4 |
| K181324 | FilmArray Pneumonia Panel plus | Biofire Diagnostics, LLC | 2018-11-15 | 181 | 2 |
| K180966 | FilmArray Pneumonia Panel | Biofire Diagnostics, LLC | 2018-11-09 | 210 | 2 |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | 2018-07-05 | 29 | 1 |
| DEN170017 | FilmArray Respiratory Panel 2 plus (RP2plus) | Biofire Diagnostics, LLC | 2017-11-24 | 253 | 0 |
| K170604 | FilmArray Respiratory Panel 2 (RP2) | Biofire Diagnostics, LLC | 2017-05-30 | 90 | 0 |
| K152579 | FilmArray Respiratory Panel EZ (RP EZ) | Biofire Diagnostics, LLC | 2016-10-03 | 389 | 0 |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray | Biofire Diagnostics, LLC | 2016-04-01 | 42 | 5 |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with Fi | Biofire Diagnostics, LLC | 2016-03-17 | 27 | 0 |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use | Biofire Diagnostics, LLC | 2016-03-15 | 25 | 2 |
| K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torc | Biofire Diagnostics, LLC | 2016-02-08 | 26 | 1 |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | Biofire Diagnostics, LLC | 2015-10-08 | 182 | 0 |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmA | Biofire Diagnostics, LLC | 2015-02-19 | 122 | 6 |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrume | Biofire Diagnostics, LLC | 2015-02-17 | 113 | 0 |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use | Biofire Diagnostics, LLC | 2015-01-30 | 87 | 2 |
| K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | 2015-01-30 | 87 | 1 |
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