Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Addent, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
132 daysmedian FDA review time
293 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182017 | Compex HD | Addent, Inc. | 2019-04-29 | 276 | 0 |
| K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Addent, Inc. | 2012-07-24 | 85 | 0 |
| K082668 | BIO-SCREEN | Addent, Inc. | 2009-01-23 | 133 | 0 |
| K072309 | MICROLUX/BLU | Addent, Inc. | 2007-11-19 | 94 | 0 |
| K062961 | MICROLUX TRANSILLUMINATOR | Addent, Inc. | 2007-02-08 | 132 | 0 |
| K061395 | CALSET COMPOSITE HEATER | Addent, Inc. | 2006-06-23 | 35 | 0 |
| K041614 | MICROLUX DL | Addent, Inc. | 2005-04-04 | 293 | 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