Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PSN — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
134 daysmedian FDA review time
366 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230448 | DeepX DermoSight Dermatoscope | Deepx Health, LLC | 2023-05-17 | 85 | 0 |
| K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | 2022-03-11 | 84 | 0 |
| K201408 | Demetra Analytics Toolkit | Barco N.V. | 2021-02-18 | 266 | 0 |
| K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019-12-13 | 72 | 0 |
| K180162 | VivaScope System | Caliber Imaging & Diagnostics, Inc. | 2018-05-03 | 104 | 0 |
| K080788 | VIVASCOPE SYSTEM, MODEL 1500, 3000 | Lucid, Inc. | 2008-09-17 | 181 | 0 |
| K062736 | SIASCOPE V | Astron Clinica Limited | 2007-09-14 | 366 | 0 |
| K040171 | MICRODERM, MODEL/VERSION 3.5 | Visiomed AG | 2004-06-08 | 134 | 0 |
| K023729 | SIASCOPE II | Astron Clinica Limited | 2003-02-03 | 89 | 0 |
| K011273 | SI ASCOPE | Astron Clinica Limited | 2002-02-20 | 300 | 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