Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
3D Systems, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
287 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | 2026-06-03 | 2 | 0 |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | 2025-12-05 | 270 | 0 |
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-10-25 | 25 | 0 |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-10-25 | 25 | 0 |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-08-30 | 127 | 0 |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-08-30 | 112 | 0 |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 2024-04-04 | 287 | 0 |
| K231585 | Vantage PSI System | 3D Systems, Inc. | 2023-06-30 | 30 | 0 |
| K183489 | D2P | 3D Systems, Inc. | 2019-08-29 | 255 | 0 |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | 2019-08-21 | 224 | 0 |
| K161841 | D2P | 3D Systems, Inc. | 2017-01-09 | 188 | 0 |
| K151285 | VSP Cranial System | 3D Systems, Inc. | 2016-09-23 | 498 | 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