Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Carol Cole Company · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
198 daysmedian FDA review time
348 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161654 | NuFACE Gel Primer | Carol Cole Company | 2016-12-30 | 198 | 0 |
| K133823 | NUFACE MINI DEVICE | Carol Cole Company | 2014-04-17 | 121 | 0 |
| K131251 | TRINITY ELE | Carol Cole Company | 2013-10-01 | 153 | 0 |
| K120560 | TRINITY WRINKLE REMOVER | Carol Cole Company | 2012-11-06 | 256 | 0 |
| K103472 | NUFACE PLUS | Carol Cole Company | 2011-11-07 | 348 | 0 |
| K072260 | NUFACE, MODEL NU-4003 | Carol Cole Company | 2007-11-27 | 105 | 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