Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Project S.R.L. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
337 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161502 | MC1 Plus | General Project S.R.L. | 2016-08-16 | 76 | 0 |
| K091615 | MED CONTOUR | General Project S.R.L. | 2010-05-06 | 337 | 0 |
| K062312 | AXIOM PULSED LIGHT SYSTEM | General Project S.R.L. | 2006-10-16 | 69 | 0 |
| K053041 | MED SCULPT | General Project S.R.L. | 2006-08-02 | 279 | 0 |
| K051508 | MED FLASH II INTENSE PULSED LIGHT SYSTEM. | General Project S.R.L. | 2005-10-05 | 120 | 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