Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3D Systems — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
335 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214093 | VSP Bolus | 3D Systems | 2022-03-30 | 92 | 0 |
| K211244 | VSP® Orthopedics System | 3D Systems | 2021-11-10 | 198 | 0 |
| K210347 | VSP System | 3D Systems | 2021-04-26 | 77 | 0 |
| K193432 | Vantage PSI System | 3D Systems | 2020-11-09 | 335 | 0 |
| K192192 | VSP System | 3D Systems | 2020-02-26 | 197 | 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