Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QYT — Predicate Candidate Screening
14 FDA 510(k) clearances under this product code; the 50 most recent screened below.
179 daysmedian FDA review time
276 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antig | Assure Tech., LLC | 2026-06-05 | 88 | 0 |
| K260095 | Heal-Check Rapid COVID-19 Antigen Self-Test | Healgen Scientific,, LLC | 2026-04-13 | 90 | 0 |
| K251916 | GenBody COVID-19 Ag Home Test | Genbody.Inc. | 2026-03-13 | 263 | 0 |
| K251595 | COVID-19 Detect Rapid Self -Test | InBios International, Inc. | 2025-10-12 | 138 | 0 |
| K251753 | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | 2025-09-05 | 88 | 0 |
| K241313 | OHC COVID-19 Antigen Self Test | Osang, LLC | 2025-05-30 | 386 | 0 |
| K243518 | BinaxNOW™ COVID-19 Antigen Self Test | Abbott Diagnostics Scarborough, Inc. | 2025-02-11 | 90 | 0 |
| K241915 | CareSuperb™ COVID-19 Antigen Home Test | Access Bio, Inc. | 2025-01-29 | 212 | 0 |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | Guangzhou Wondfo Biotech Co., Ltd. | 2024-09-30 | 143 | 0 |
| K240728 | CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test | CorDx, Inc. | 2024-06-21 | 95 | 0 |
| K233842 | iHealth COVID-19 Antigen Rapid Test | Ihealth Labs, Inc. | 2024-05-31 | 179 | 0 |
| K233373 | Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. | 2024-04-19 | 200 | 0 |
| K231795 | QuickVue COVID-19 Test | Quidel Corporation | 2024-03-22 | 276 | 0 |
| K230828 | Flowflex COVID-19 Antigen Home Test | ACON Laboratories, Inc. | 2023-11-09 | 227 | 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