Biofire Defense, LLC: FDA clearances and approvals
Biofire Defense, LLC has 8 FDA 510(k) clearances (first 2017, latest 2026), plus 2 De Novo decisions, across 5 product codes in 1 review panel. Median 510(k) review time: 91 days. Since 2017 its median was 91 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Biofire Defense, LLC. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 92 |
| 2021 | 1 | 203 |
| 2022 | 2 | 138 |
| 2023 | 1 | 526 |
| 2024 | 0 | — |
| 2025 | 1 | 90 |
| 2026 | 1 | 73 |
Review time against the same product codes
Since 2017, Biofire Defense, LLC's cleared 510(k)s took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PRD | 3 | 2 | |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 2 | 2 |
| QMV | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness | 2 | 1 |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test | 2 | 2 |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | 1 | 1 |
Review panels
- Microbiology (7)
Most recent Biofire Defense, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261475 | BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit | PMN | 2026-07-17 | 73 |
| K243822 | BioFire Warrior Panel; BioFire Warrior Panel Control Kit | PRD | 2025-03-12 | 90 |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | QVR | 2023-03-22 | 526 |
| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | QMV | 2022-10-20 | 209 |
| K221460 | BioFire COVID-19 Test 2 | QQX | 2022-07-25 | 67 |
| K211079 | BioFire COVID-19 Test 2 | QQX | 2021-11-01 | 203 |
| K202382 | FilmArray Global Fever Panel External Control Kit | PMN | 2020-11-20 | 92 |
| K170883 | FilmArray NGDS Warrior Panel | PRD | 2017-06-22 | 90 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200043 | De Novo | Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness | 2020-11-20 |
| DEN160048 | De Novo | 2017-02-14 |
Recalls
4 product recalls in 4 recall events; 2 initiated in the last five years. Most recent: 2026-07-16.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Biofire Defense, LLC is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07221097: Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses (Recruiting, started 2025-09-29)
Frequently asked questions
How many FDA 510(k) clearances does Biofire Defense, LLC have?
Biofire Defense, LLC has 8 FDA 510(k) clearances (first 2017, latest 2026), plus 2 De Novo decisions, across 5 product codes in 1 review panel.
How long does FDA take to clear Biofire Defense, LLC's 510(k)s?
The median time from FDA receipt to decision across Biofire Defense, LLC's cleared 510(k)s is 91 days. Since 2017: 91 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Biofire Defense, LLC make?
Its most frequent FDA product codes are PRD (device, 3); PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, 2); QMV (Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness, 2).
Has Biofire Defense, LLC had device recalls?
openFDA lists 4 product recalls in 4 recall events by a recalling firm whose name matches Biofire Defense, LLC; the most recent began 2026-07-16. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 8 Biofire Defense, LLC clearances with predicates and recalls
- Run predicate analysis for product code PRD, Biofire Defense, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.