Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diomed, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
133 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041957 | EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS | Diomed, Inc. | 2004-12-01 | 133 | 1 |
| K023543 | EVLT KIT AND D15PLUS AND D30PLUS DIODE | Diomed, Inc. | 2002-12-02 | 41 | 0 |
| K013499 | DIOMED 15 PLUS AND DIOMED 30PLUS LASERS | Diomed, Inc. | 2001-11-16 | 25 | 0 |
| K000982 | A100 AESTHETIC DIODE LASER | Diomed, Inc. | 2000-05-01 | 35 | 0 |
| K990014 | DIOSCAN | Diomed, Inc. | 1999-02-26 | 53 | 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