Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Solarc Systems, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103204 | SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT F | Solarc Systems, Inc. | 2011-04-27 | 177 | 0 |
| K061589 | SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT F | Solarc Systems, Inc. | 2006-08-04 | 57 | 0 |
| K031800 | SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT F | Solarc Systems, Inc. | 2003-09-10 | 91 | 0 |
| K935572 | SOLARC 1000 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT | Solarc Systems, Inc. | 1994-03-07 | 109 | 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