Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Premier North America, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
550 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233862 | NUNA LUX (NUNL528) | Premier North America, Inc. | 2024-03-01 | 86 | 0 |
| K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | 2023-11-14 | 75 | 0 |
| K220735 | Avologi Gel Primer (Model: Av25) | Premier North America, Inc. | 2023-09-15 | 550 | 0 |
| K214100 | Luminice | Premier North America, Inc. | 2022-02-24 | 57 | 0 |
| K213841 | ENEO TOTALE (Model: ENEOT947) | Premier North America, Inc. | 2022-01-06 | 28 | 0 |
| K181659 | Avologi ENEO | Premier North America, Inc. | 2018-07-26 | 31 | 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