Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Allergan — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
212 daysmedian FDA review time
266 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203229 | NATRELLE INSPIRA Single Use Sizers for Gel Implants | Allergan | 2021-06-02 | 212 | 0 |
| K193589 | TrueTear Intranasal Tear Neurostimulator | Allergan | 2020-08-31 | 252 | 0 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018-12-21 | 266 | 0 |
| K182054 | Natrelle 133S Tissue Expander | Allergan | 2018-08-29 | 29 | 0 |
| DEN170086 | TrueTear Intranasal Tear Neurostimulator | Allergan | 2018-05-17 | 206 | 0 |
| K123128 | SERI SURGICAL SCAFFOLD | Allergan | 2013-04-25 | 203 | 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