Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QKQ — Predicate Candidate Screening
15 FDA 510(k) clearances under this product code; the 50 most recent screened below.
238 daysmedian FDA review time
377 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253561 | Aperio iQC DX Software | Leica Biosystems Imaging, Inc. | 2026-08-07 | 263 | 0 |
| K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026-08-05 | 100 | 0 |
| K243449 | INFINITT DPS | Infinitt Healthcare Co., Ltd. | 2025-12-09 | 397 | 0 |
| K252762 | HALO AP Dx | Indica Labs, LLC | 2025-11-25 | 88 | 0 |
| K243391 | AISight Dx | PathAI, Inc. | 2025-06-26 | 238 | 0 |
| K250968 | PathPresenter Clinical Viewer | Pathpresenter Corporation | 2025-06-20 | 81 | 0 |
| K250414 | CaloPix | Tribun Health | 2025-05-14 | 90 | 0 |
| K242244 | Viewer+ | Lumea, Inc. | 2025-03-14 | 226 | 0 |
| K241273 | FullFocus | Paige.Ai, Inc. | 2025-01-09 | 248 | 0 |
| K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | 2024-10-28 | 269 | 0 |
| K233126 | aetherSlide | Aetherai Co., Ltd. | 2024-05-30 | 246 | 0 |
| K212361 | Novo | PathAI, Inc. | 2022-08-11 | 377 | 0 |
| K210811 | Dynamyx Digital Pathology Software | Inspirata, Inc. | 2022-03-01 | 349 | 0 |
| K201005 | FullFocus | Paige.Ai, Inc. | 2020-07-15 | 90 | 0 |
| K193054 | Sectra Digital Pathology Module | Sectra AB | 2020-03-31 | 151 | 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