Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Transdermal Cap, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203826 | LaserCap Family of Lasers 300, 224, 120 & 80 | Transdermal Cap, Inc. | 2021-03-29 | 90 | 0 |
| K161875 | LaserCap300, LaserCap224, LaserCap120, LaserCap80 | Transdermal Cap, Inc. | 2016-09-30 | 84 | 0 |
| K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015-07-22 | 134 | 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