Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
AVAVA, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
214 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252155 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025-10-20 | 103 | 0 |
| K250402 | AVAVA™ Skin Treatment System | AVAVA, Inc. | 2025-04-14 | 61 | 0 |
| K223871 | Miria Skin Treatment System | AVAVA, Inc. | 2023-06-22 | 181 | 0 |
| K221268 | SR-1 Skin Treatment System | AVAVA, Inc. | 2022-11-21 | 203 | 0 |
| K213726 | PL-1 Skin Treatment System | AVAVA, Inc. | 2022-06-28 | 214 | 0 |
| K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021-04-13 | 197 | 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