Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QVF — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
181 daysmedian FDA review time
329 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | 2026-06-01 | 179 | 0 |
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 | 180 | 0 |
| K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | 2025-06-16 | 181 | 0 |
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 | 134 | 0 |
| K233358 | SCoV-2 Ag Detect Rapid Test | InBios International, Inc. | 2024-08-23 | 329 | 0 |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC | 2024-04-19 | 255 | 0 |
| K231187 | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | 2024-01-23 | 272 | 0 |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control | Quidel Corporation | 2023-12-13 | 26 | 0 |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control | Quidel Corporation | 2023-03-08 | 265 | 0 |
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