Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aerin Medical, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
253 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 | 90 | 0 |
| K242630 | Aerin Console | Aerin Medical, Inc. | 2024-12-10 | 98 | 0 |
| K240253 | Reach Needle | Aerin Medical, Inc. | 2024-03-21 | 51 | 0 |
| K221907 | RhinAer® Stylus (FG1393) | Aerin Medical, Inc. | 2022-07-29 | 29 | 0 |
| K200300 | VivAer Stylus | Aerin Medical, Inc. | 2020-04-13 | 67 | 1 |
| K192471 | RHIN1 Stylus | Aerin Medical, Inc. | 2019-12-20 | 101 | 0 |
| K172529 | Vivaer ARC Stylus | Aerin Medical, Inc. | 2017-12-05 | 106 | 0 |
| K162810 | InSeca ARC Stylus, Aerin Console | Aerin Medical, Inc. | 2017-01-11 | 97 | 0 |
| K161994 | Aerin Medical Stylus | Aerin Medical, Inc. | 2016-09-22 | 65 | 0 |
| K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | 2015-11-19 | 253 | 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